Compella™Surface P642ACAP0100000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887761996779), received between Feb 22, 2023 and Feb 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER INITIALLY REPORTED THE COMPELLA ¿CONNECTING TUBE¿ (THAT KEEPS THE CENTER SECTION OF THE DEVICE INFLATED) EASILY BECOMES UNDONE, LEAVING THE PATIENT LYING ON A FLAT MATTRESS AND ALLEGED THE PATIENT HAD A PRESSURE ULCER. FOLLOW UP WITH THE CUSTOMER CONFIRMED THE PATIENT DEVELOPED A DEEP TISSUE INJURY TO BOTH THEIR SACRUM AND LEFT BUTTOCKS DUE TO USING THE DEVICE WITH HOSES DISCONNECTED (DEFLATED) AND ADDITIONALLY STATING THE PATIENT WAS NOT TURNED PER CUSTOMER POLICY. MEDICAL INTERVENTION TO BOTH THE SACRUM AND BUTTOCKS INCLUDED: CLEANING WITH NORMAL SALINE, APPLICATION OF Z GUARD AND SANTYLE TO WOUND. THE BED WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16417361 ↗