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POWER X1
Model 0015807 · FERNO-WASHINGTON, INC. · DI 00190790002183
FPO — Stretcher, Wheeled · Class II · 21 CFR 880.6910
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (405)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 350 · Injury: 52 · Death: 3
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
2.41
2019-02
0
1.71
2019-03
0
3
2019-04
2
2.46
2019-05
0
1.89
2019-06
0
2.33
2019-07
0
2.48
2019-08
3
2
2019-09
0
1
2019-10
0
2.59
2019-11
3
1.8
2019-12
0
2.5
2020-01
0
2.8
2020-02
0
2.5
2020-03
0
1.17
2020-04
0
3
2020-05
7
2.8
2020-06
2
1.67
2020-07
0
2.92
2020-08
0
1.15
2020-09
3
1.5
2020-10
5
2.92
2020-11
0
2.25
2020-12
0
1
2021-01
3
4.96
2021-02
0
3.35
2021-03
0
1.67
2021-04
0
2.43
2021-05
3
2
2021-06
0
1.89
2021-07
0
2.47
2021-08
0
1.6
2021-09
0
1.2
2021-10
0
2.83
2021-11
0
1.17
2021-12
0
1.67
2022-01
3
2.72
2022-02
0
1
2022-03
0
1.75
2022-04
0
3.1
2022-05
0
2.33
2022-06
0
1
2022-07
0
3.23
2022-08
3
1.75
2022-09
9
4
2022-10
0
3.29
2022-11
0
1.43
2022-12
3
2
2023-01
0
3.16
2023-02
0
1.67
2023-03
6
2.3
2023-04
6
3.68
2023-05
6
2.33
2023-06
3
2.4
2023-07
20
3.68
2023-08
0
1.63
2023-09
3
1.77
2023-10
0
3.5
2023-11
0
2.5
2023-12
0
2.4
2024-01
4
3.57
2024-02
14
3.17
2024-03
0
1.71
2024-04
45
4.21
2024-05
3
1.43
2024-06
9
2.3
2024-07
15
3.51
2024-08
5
1.57
2024-09
24
7
2024-10
11
4
2024-11
18
5.43
2024-12
2
4.6
2025-01
8
3.77
2025-02
19
6.67
2025-03
35
8
2025-04
8
3.81
2025-05
9
6
2025-06
2
3
2025-07
10
3.23
2025-08
12
5.67
2025-09
8
5
2025-10
7
3.47
2025-11
12
5.67
2025-12
6
3.22
2026-01
8
3.13
2026-02
6
4.67
2026-03
3
5.11
2026-04
6
3.84
2026-05
0
10.43
2026-06
3
7.43
This device (reports/month)Average device in FPO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — FERNO-WASHINGTON, INC.