P500 Surface P005723CAP01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887761999480), received between Sep 24, 2021 and Jul 9, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Defective Component; Defective Component

  IT WAS REPORTED A PATIENT DEVELOPED PRESSURE SORES WHILE USING A P500 SURFACE BED. THE PATIENT HAS HAD THE BED FOR APPROXIMATELY SEVEN YEARS AND STATES IT ¿SLUMPS NOTICEABLY IN THE MIDDLE;¿ HOWEVER, NO ERROR MESSAGES ARE TRIGGERED. THE PATIENT HAS A STAGE IV WOUND TO THE RIGHT OUTER CALF; A STAGE III WOUND TO THE RIGHT HEEL AND A STAGE III WOUND TO THE UPPER LEFT BUTTOCK. THE PATIENT HAS BEEN UNDER CONTINUAL HOME HEALTH CARE SINCE THE WOUND FIRST DEVELOPED (NOT FURTHER SPECIFIED). FOR APPROXIMATELY SIX TO EIGHT MONTHS THE PATIENT MADE PERIODIC VISITS TO THE WOUND CARE CLINIC, WHERE THE MEDICAL TEAM RELAYED ORDERS FOR THE HOME CARE TEAM ON THE CALF AND HEEL WOUNDS. THE STAGE FOUR RIGHT OUTER CALF WOUND BEGAN AS A SMALL LUMP, THEN BROKE DOWN RAPIDLY AND HAS RESISTED HEALING FOR MORE THAN EIGHTEEN MONTHS. THE WOUND IS NOW APPROXIMATELY TWELVE CENTIMETERS IN LENGTH AND APPROXIMATELY THREE CENTIMETERS WIDE. THE PATIENT¿S TENDONS ARE VISIBLE ON THE UPPER PORTION OF THE WOUND. THE PATIENT UNDERWENT A VENOUS ABLATION TO THE RIGHT OUTER CALF, WHICH HAS DRAMATICALLY REDUCED SWELLING IN THE LOWER LEG; HOWEVER, THE WOUND HAS NOT YET SHOWN SIGNS OF HEALING. THE PATIENT WEARS A PROTECTIVE BOOT I

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22457114 ↗
• InjuryApr 4, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER INITIALLY CONTACTED BAXTER TECHNICAL SUPPORT TO REPORT THAT THE MATTRESS TOPPER (COVERLET) OF HIS P500 THERAPY SURFACE WAS SPLIT AND HE DEVELOPED A SKIN TEAR AND SKIN BREAKDOWN. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19044564 ↗
• MalfunctionSep 24, 2021Sparking; Sparking

  HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED HAD POWER CORD DAMAGE WITH SPARKS. 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 12526292 ↗