Compella™Surface P642AREN0100000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887761996717), received between Mar 23, 2022 and Sep 3, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A PATIENT SUSTAINED AN UNSTAGEABLE PRESSURE ULCER IN CONJUNCTION WITH A COMPELLA MATTRESS. THE PATIENT STATED WHEN THEY ¿RAISED THEIR HEAD AND KNEES THEY COULD FEEL THE METAL PART OF THE BED.¿ THE PATIENT WAS FOUND TO HAVE A NEW OPEN AREA ON THE PATIENT¿S BUTTOCKS. THE NURSE WAS UNABLE TO STAGE THE WOUND DUE TO ¿MINIMAL SLOUGH NOTED.¿ ADDITIONALLY, THE WOUND WAS MEASURED AT 2.2 CM X 1.5 CM X 0.1 CM (ESTIMATED). THE PATIENT WAS TREATED WITH MEDIHONEY AND COLLAGEN APPLICATION TO THE WOUND AND COVERED WITH A DRY PROTECTIVE DRESSING. THE BAXTER SERVICE TECHNICIAN INSPECTED THE BED. THE TECHNICIAN NOTED THE BED¿S CPR VALVE WAS OPEN, PUTTING THE BED INTO CPR MODE AND CAUSING THE MATTRESS TO DEFLATE. THE TECHNICIAN CLOSED THE CPR VALVE TO RESOLVE THE ISSUE, AND THE BED IS FUNCTIONING AS DESIGNED. THE CAUSE OF THE EVENT IS LIKELY DUE TO THE BED¿S CPR MODE BEING ENGAGED WHICH DID NOT ALLOW THE BED¿S MATTRESS TO REINFLATE (USER ERROR). WHEN THE CPR FUNCTION IS ENGAGED/ACTIVATED AIR IS RELEASED FROM THE BED¿S SURFACE UNTIL THE SURFACE IS COMPLETELY DEFLATED. THE DEVICE INSTRUCTIONS FOR USE STATE THE FOLLOWING WHEN USING THE BED¿S CPR CONTROLS. ¿TO INFLATE THE AIR SURFACE AFTER

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22954436 ↗
• MalfunctionDec 2, 2024Sparking; Sparking

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE COMPELLA AIR MATTRESS, NA, R POWER CORD SPARKED AND SMOKED DUE TO SHORT. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED DURING PATIENT USE. THE REPORTER DID NOT KNOW IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN IF ANY SECOND DEVICE WAS ALSO INVOLVED. THE CUSTOMER DID NOT KNOW IF THIS EVENT WAS ALREADY COMMUNICATED TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821279 ↗
• InjurySep 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A COMPELLA BED HAD NO AIR IN THE CENTER AND THE PATIENT DEVELOPED A DEEP TISSUE INJURY (DTI). THE BED WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15335601 ↗
• InjuryMar 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THE COMPELLA THE MATTRESS WAS NOT INFLATING, AND THE BED DISPLAYED AN ERROR CODE 6. THE CUSTOMER ALSO REPORTED THE PATIENT HAD A NEW DEEP TISSUE INJURY (DTI) POTENTIALLY CAUSED BY THE BED NOT INFLATING PROPERLY. THE BED WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13862956 ↗