NA 05.725.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587025919), received between Jan 16, 2019 and Jan 7, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Intermittent Loss of Power” (3 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. 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.

• MalfunctionJan 7, 2025Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THE PROCEDURE WAS AN ORIF FOR BLOWOUT FRACTURE PERFORMED ON (B)(6), 2024. WHEN PREPARING THE COMPACT WATER BATH, THE POWER CORD OR MAIN UNIT CONTACT WAS FAULTY. THE POWER KEPT TURNING ON AND OFF, AND IT COULD NOT BE HEATED. THEREFORE, STERILE SALINE SOLUTION WAS HEATED, AND THE SURGEON MANAGED TO PERFORM BENDING WITHOUT INTERFERING WITH THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090930 ↗
• InjuryDec 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, A WATER COMPACT BATH DESIGNED FOR REASONABLE FIXATION SYSTEM WAS USED AS FLUID WARMER AND SCALDED THE PATIENT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) COMPACT WATER BATH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 11029337 ↗
• MalfunctionFeb 6, 2020Intermittent Loss of Power; Intermittent Loss of Power

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SWITCH LAMP ON THE WATER BATH (05.725.010) WAS SWITCHING ON AND OFF REPEATEDLY DURING THE MAXILLARY AND MANDIBULAR OSTEOTOMY SURGERY. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPACT WATER BATH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677898 ↗
• InjuryJan 16, 2019Intermittent Loss of Power; Intermittent Loss of Power

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, A COMPACT WATER BATH WAS PLANNED TO USE FOR BENDING AN UNKNOWN RAPIDSORB PLATE FOR AN UNKNOWN SURGERY. HOWEVER, THE DEVICE WAS REPEATEDLY OPERATED OR STOPPED AFTER TURNING THE SWITCH ON. THE SURGERY WAS COMPLETED WITHOUT PLATE BENDING DUE TO SURGEON'S DECISION. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN RAPIDSORB PLATES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) COMPACT WATER BATH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8253980 ↗