Synergy® Surface P6881CAPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761016644), received between Aug 2, 2022 and May 7, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Sparking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AIR CELLS ON THE SYNERGY ELITE MATTRESS ARE SHIFTING TO ONE SIDE AND DO NOT SEEM TO FULLY INFLATE AND THE CUSTOMER HAS A NEW PRESSURE WOUND. CUSTOMER INDICATED PRIOR HISTORY OF FLAP SURGERY 3 1/2 YEARS AGO, DID NOT PROVIDE DETAILS OF LOCATION, AND ABOUT 6-8 MONTHS AGO PATIENT STARTED WITH A NEW PRESSURE SORE ON THE SACRUM AND IT IS STAGE 4. THE MEDICAL INTERVENTION PROVIDED FOR THE PRESSURE WOUND IS REGULAR DRESSING CHANGES AND THEY ARE GOING TO START USING A WOUND VAC AND THE HYPERBARIC CHAMBER. IT WAS ALSO REPORTED THE PATIENT WAS TRANSFERRED TO A REHAB FACILITY WHERE THE EXPECTED DURATION OF STAY WAS INITIALLY ESTIMATED AT 6¿8 MONTHS BUT WAS LATER REVISED TO APPROXIMATELY 20 DAYS. THE PATIENT STATED THAT THE MATTRESS WAS MANIPULATED BY A NON-BAXTER EMPLOYEE, DID NOT PROVIDE SPECIFIC DATE ON WHEN THIS OCCURRED. THE PERSON SEWED THE MATTRESS AIR CELLS AND AFTER 2-3 MONTHS THE CELLS COME LOOSE AND MATTRESS WOULD SEPARATE. INSTRUCTIONS IN THE IFU ARE OUTLINE USERS: ¿UNZIP THE TOP COVERLET FROM THE BOTTOM ENCASEMENT AND EXAMINE THE AIR CELLS AND AIR TUBES FOR LEAKS. IF A LEAK IS FOUND, CONTACT BAXTER TECHNICAL SUPPORT FOR ASSISTANCE.¿. NO FURTHER INFORMATION

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 25115542 ↗
• MalfunctionAug 2, 2022Sparking; Sparking

  HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE POWER CORD WAS DAMAGED; IT WAS SPARKING AND IT SHORTED OUT. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152958 ↗