Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
16 linked reportsMalfunction 16
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2
2019-02
0
4
2019-03
0
3
2019-04
0
6.5
2019-05
0
2.33
2019-06
0
4.25
2019-07
0
2
2019-08
0
2
2019-09
0
4
2019-10
0
2.4
2019-11
0
2
2019-12
0
1.8
2020-01
0
1.5
2020-02
0
1.5
2020-03
0
2.33
2020-04
0
2
2020-05
0
1.33
2020-07
0
2
2020-08
0
1.67
2020-09
0
1.5
2020-10
0
2.2
2020-11
0
1
2020-12
0
2
2021-02
0
7
2021-03
0
6.67
2021-04
0
3
2021-05
0
2.5
2021-06
0
12.25
2021-07
0
22.5
2021-08
0
16.5
2021-09
0
8.5
2021-10
0
30
2021-11
0
22
2021-12
0
11.75
2022-01
0
12.67
2022-02
0
9
2022-03
0
34
2022-04
0
3.25
2022-05
0
3
2022-06
2
1.67
2022-07
0
3
2022-08
2
2
2022-09
4
4
2022-10
2
2
2022-11
0
2
2022-12
0
2
2023-02
0
2.67
2023-03
0
3
2023-04
0
2
2023-05
0
2.33
2023-06
0
2.5
2023-07
2
3
2023-08
0
1.67
2023-09
2
2.75
2023-10
0
2
2023-11
0
3
2023-12
0
2.33
2024-01
0
3.5
2024-02
0
3.5
2024-03
0
2
2024-04
0
3.25
2024-05
0
2
2024-06
0
2.33
2024-07
0
3.5
2024-08
0
1.67
2024-09
0
1.5
2024-10
0
5
2024-11
0
6.67
2024-12
0
4
2025-01
0
1.6
2025-02
0
3.5
2025-03
0
3
2025-04
0
1
2025-05
0
3
2025-06
0
1.8
2025-07
0
5
2025-09
0
1.5
2025-10
2
2.83
2025-11
0
3
2025-12
0
2
2026-01
0
2
2026-02
0
2.5
2026-03
0
3.2
2026-04
0
2
2026-05
0
1.25
2026-06
0
3.83
This device (reports/month)Average device in HIG (reports/device/month)
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2023-07-17
Z-2629-2023
Class II
Open, Classified
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overloadDistribution: Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
1287 units
code info di
2019-08-14
Z-2767-2019
Class II
Terminated
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.Distribution: US Nationwide Distribution
322 units
clearance family
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-10-16
3002914049-2025-00003
Malfunction
Available
exact di
2023-09-13
3002914049-2023-00009
Malfunction
Available
exact di
2023-07-28
3002914049-2023-00006
Malfunction
Available
exact di
2022-10-04
3002914049-2022-00010
Malfunction
Available
exact di
2022-09-24
3002914049-2022-00008
Malfunction
Available
exact di
2022-09-15
3002914049-2022-00007
Malfunction
Available
exact di
2022-08-09
3002914049-2022-00006
Malfunction
Available
exact di
2022-06-17
3002914049-2022-00004
Malfunction
Available
exact di
Showing the most recent 8 of 16 linked reports.
Regulatory clearances
510(k)K172040Substantially equivalent (SESE) · 2018-02-05clearance family
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.