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Adverse-event reports (MAUDE)

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.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-12-16Z-1197-2025Class IIOpen, ClassifiedThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.Distribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.4 unitsclearance family
2024-12-16Z-1199-2025Class IIOpen, ClassifiedThere is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.Distribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.3 unitscode info di
2024-02-15Z-1171-2025Class IIOpen, ClassifiedUsers were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .Distribution: US distribution to states of: AL, TX, NV20 unitsclearance family
2024-02-15Z-1172-2025Class IIOpen, ClassifiedUsers were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .Distribution: US distribution to states of: AL, TX, NV7 unitclearance family
Regulatory clearances
  • 510(k)K232627Substantially equivalent (SESE) · 2024-04-18clearance family
  • 510(k)K230866Substantially equivalent (SESE) · 2023-06-29clearance family

Predicate lineage

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.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-11-27OAIOfficial action indicatedAugustine Temperature Management, LLC5
2024-11-27OAIOfficial action indicatedAugustine Temperature Management, LLC5
2024-03-21WLWarning LetterAugustine Temperature Management, LLC—
2024-03-21WLWarning LetterAugustine Temperature Management, LLC—
2023-09-19OAIOfficial action indicatedAugustine Temperature Management, LLC2
2023-09-19OAIOfficial action indicatedAugustine Temperature Management, LLC2
2017-01-04VAIVoluntary action indicatedAugustine Temperature Management, LLC3
2017-01-04VAIVoluntary action indicatedAugustine Temperature Management, LLC3
2012-09-26NAINo action indicatedAugustine Temperature Management, LLC0
2012-09-26NAINo action indicatedAugustine Temperature Management, LLC0
2012-07-24WLWarning LetterAugustine Temperature Management, LLC—
2012-07-24WLWarning LetterAugustine Temperature Management, LLC—
2010-07-14VAIVoluntary action indicatedAugustine Temperature Management, LLC7
2010-07-14VAIVoluntary action indicatedAugustine Temperature Management, LLC7
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