IsoAir 2941 (REF 2941-000-001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327504002), received between Nov 24, 2020 and Apr 1, 2026 — classified as 3 deaths, 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Material Too Soft/Flexible

  IT WAS REPORTED THAT A PATIENT SUSTAINED A DEEP TISSUE INJURY TO THE HEEL. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24756882 ↗
• MalfunctionMar 26, 2026Material Too Soft/Flexible

  IT WAS REPORTED THAT A PATIENT SUSTAINED A DTI SACRUM PRESSURE INJURY. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24705756 ↗
• MalfunctionMar 26, 2026Material Too Soft/Flexible

  IT WAS REPORTED THAT A PATIENT SUSTAINED A 1 STAGE 2 COCCYX PRESSURE INJURY. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24705739 ↗
• MalfunctionMar 26, 2026Material Too Soft/Flexible

  NO NEW INFORMATION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24705738 ↗
• MalfunctionMar 26, 2026Material Too Soft/Flexible

  IT WAS REPORTED THAT A PATIENT SUSTAINED A DTI HEEL PRESSURE INJURY. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24705732 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL SURVEY THAT A 68-YEAR-OLD, MODERATELY OBESE, MALE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CONGESTIVE HEART FAILURE (CHF) EXACERBATION, FLUID OVERLOAD, AND A STAGE 2 PRESSURE INJURY IN THE TROCHANTER AREA. THE PATIENT PRESENTED WITH A BRADEN SCORE OF 12. DURING THE TREATMENT PERIOD, THE SEVERITY OF THE PRESSURE INJURIES DECREASED BY 60% VOLUME. ADDITIONALLY, ONE STAGE 2 AND ONE STAGE 3 PRESSURE INJURIES DEVELOPED ON THE HEELS AND SACRAL AREA. THE PATIENT RECEIVED MEDICATION AND OTHER WOUND CARE TREATMENTS RESULTING IN A NOTABLE IMPROVEMENT IN HIS OVERALL PHYSIOLOGICAL CONDITION. THE SURVEY RESPONDENT INDICATED THAT THERE WAS NO DEVICE MALFUNCTION AND THAT THE PRODUCT WAS USED ACCORDING TO ITS INDICATIONS FOR USE. SEVERAL COMORBID CONDITIONS AND MEDICATIONS THAT MAY IMPEDE WOUND HEALING WERE ALSO NOTED. GIVEN THE MULTIFACTORIAL NATURE OF PRESSURE INJURY DEVELOPMENT, IT CANNOT BE CONCLUSIVELY DETERMINED THAT THE PRODUCT CONTRIBUTED TO THE PATIENT¿S OUTCOME. NONETHELESS, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL ATTEMPTS ARE BEING MADE TO OBTAIN MORE INFORMATION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21335270 ↗
• DeathFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL SURVEY THAT A 54-YEAR-OLD, OVERWEIGHT, MALE PATIENT WAS EMERGENTLY ADMITTED TO THE INTENSIVE CARE UNIT WITH ¿CARDIAC RESUSCITATION WITH RSOC (RETURN OF SPONTANEOUS CIRCULATION).¿ THE PATIENT PRESENTED WITH A BRADEN SCORE OF 12 AND A STAGE 2 PRESSURE INJURY INVOLVING THE SACRAL AREA. DURING THE TREATMENT PERIOD, THE PRESSURE INJURY DID NOT IMPROVE AND PROGRESSED TO A STAGE 3 PRESSURE INJURY. ADDITIONALLY, IT WAS REPORTED THAT TWO NEW STAGE 2 PRESSURE INJURIES DEVELOPED ON THE HEELS, CONTRIBUTING TO A DETERIORATION IN THE PATIENT¿S HEALTH, RESULTING IN PROLONGED HOSPITALIZATION AND ULTIMATELY, DEATH. THE SURVEY RESPONDENT NOTED THAT THERE WAS NO DEVICE MALFUNCTION, AND THE PRODUCT WAS BEING USED IN ACCORDANCE WITH THE INDICATIONS FOR USE. SEVERAL COMORBID CONDITIONS AND MEDICATIONS ARE NOTED, WHICH MAY IMPEDE WOUND HEALING. GIVEN THE PREVIOUS INFORMATION AND THE MULTI-FACTORIAL NATURE OF PRESSURE INJURY DEVELOPMENT IT CANNOT BE CONCLUSIVELY DETERMINED THAT THE PRODUCT HAD A CAUSAL RELATIONSHIP OR CONTRIBUTION TO THE PATIENT¿S OUTCOME. NONETHELESS, WE ARE CHOOSING TO FILE THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. NO ADDITIONAL INFORMATION WAS PROVID

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21335268 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL SURVEY THAT A 44-YEAR-OLD, UNDERWEIGHT, PARAPLEGIC FEMALE PATIENT WAS ADMITTED TO THE HOSPITAL WITH UROSEPSIS AND A STAGE 3 PRESSURE INJURY IN THE SACRAL AREA. THE PATIENT PRESENTED WITH A BRADEN SCORE OF 8. DURING THE TREATMENT PERIOD, THE SEVERITY OF THE PRESSURE INJURY REMAINED UNCHANGED. ADDITIONALLY, TWO NEW STAGE 2 PRESSURE INJURIES DEVELOPED ON THE HEELS. THE PATIENT RECEIVED MEDICATION AND OTHER WOUND CARE TREATMENTS. THE SURVEY RESPONDENT INDICATED THAT THERE WAS NO DEVICE MALFUNCTION AND THAT THE PRODUCT WAS USED ACCORDING TO ITS INDICATIONS FOR USE. SEVERAL COMORBID CONDITIONS AND MEDICATIONS THAT MAY IMPEDE WOUND HEALING WERE ALSO NOTED. GIVEN THE MULTIFACTORIAL NATURE OF PRESSURE INJURY DEVELOPMENT, IT CANNOT BE CONCLUSIVELY DETERMINED THAT THE PRODUCT CONTRIBUTED TO THE PATIENT¿S OUTCOME. NONETHELESS, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL ATTEMPTS ARE BEING MADE TO OBTAIN MORE INFORMATION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21326937 ↗
• DeathFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL SURVEY THAT A 67-YEAR-OLD, UNDERWEIGHT, FEMALE PATIENT WAS EMERGENTLY ADMITTED TO THE INTENSIVE CARE UNIT WITH ¿SEPSIS FROM PRESSURE ULCERS.¿ THE PATIENT PRESENTED WITH A BRADEN SCORE OF 11 AND 4 PRESSURE INJURIES AT THE ONSET OF TREATMENT. ONE STAGE 3 AND ONE STAGE 4 FOR PRESSURE INJURY INVOLVING THE HEEL AREA. ADDITIONALLY, THE PATIENT PRESENTED WITH TWO UNSTAGEABLE PRESSURE INJURIES INVOLVING THE SACRAL AND TROCHANTERIC AREAS. DURING THE TREATMENT PERIOD, THE TWO PRESSURE INJURIES INVOLVING THE HEELS IMPROVED BY 40% REDUCTION IN VOLUME. HOWEVER, TWO NEW STAGE 2 PRESENTING IN THE ELBOW AREA, REPORTEDLY CONTRIBUTING TO A DETERIORATION IN THE PATIENT¿S HEALTH, RESULTING IN PROLONGED HOSPITALIZATION AND ULTIMATELY, DEATH. THE SURVEY RESPONDENT NOTED THAT THERE WAS NO DEVICE MALFUNCTION, AND THE PRODUCT WAS BEING USED IN ACCORDANCE WITH THE INDICATIONS FOR USE. SEVERAL COMORBID CONDITIONS AND MEDICATIONS ARE NOTED WHICH MAY IMPEDE WOUND HEALING. GIVEN THE PREVIOUS INFORMATION AND THE MULTI-FACTORIAL NATURE OF PRESSURE INJURY DEVELOPMENT IT CANNOT BE CONCLUSIVELY DETERMINED THAT THE PRODUCT HAD A CAUSAL RELATIONSHIP OR CONTRIBUTION TO THE PATIENT¿S O

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21326830 ↗
• DeathFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21314561 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21314559 ↗
• InjuryNov 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED A PATIENT DEVELOPED A BED SORE FROM A STRYKER MATTRESS. NO INFORMATION HAS BEEN PROVIDED REGARDING THE SEVERITY OR TREATMENT OF THE BED SORES. ATTEMPTS HAVE BEEN MADE TO REACH THE CUSTOMER FOR MORE INFORMATION; HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THESE ATTEMPTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10896345 ↗
• InjuryNov 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED A PATIENT DEVELOPED A BED SORE FROM A STRYKER MATTRESS. NO INFORMATION HAS BEEN PROVIDED REGARDING THE SEVERITY OR TREATMENT OF THE BED SORES. ATTEMPTS HAVE BEEN MADE TO REACH THE CUSTOMER FOR MORE INFORMATION; HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THESE ATTEMPTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10896234 ↗