Berkette Beach Chair Limb Positioner 711200Recalls & reported problems
Aspen Surgical Products, Inc. · Intended to support and maintain the position of an anesthetized patient during surgery · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840113230662), received between Apr 24, 2026 and Jul 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25828909 ↗MalfunctionApr 24, 2026Break
COMPLAINANT ALLEGES "THIS MORNING WE HAD THE HANDLE ON THE BERKETTE BREAK OFF WHILE GETTING THE PATIENT POSITIONED. THIS HAPPENED 3 TIMES TO 3 DIFFERENT PRODUCTS ALL WITH THE SAME LOT# OF 110525. HOPEFULLY YOU CAN TELL FROM THE PICTURES BELOW, BUT THE HANDLE SNAPPED WHERE IT IS COVERED BY THE GRIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24981539 ↗
Other SUPPORT, PATIENT POSITION devices
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- PILLOW, GENTLETOUCH, 7 INCH RT 1937Mizuho Orthopedic Systems, Inc. · Support, Patient Position11 reports
- Battalion 27428Alphatec Spine, Inc. · SUPPORT, PATIENT POSITION3 reports
- ACUFEX 72205103Smith & Nephew, Inc. · SUPPORT, PATIENT POSITION2 reports
- Medline MSC50023Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- MEDLINE NON081147Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- Olympic Vac-Pac Size 30Natus Medical Incorporated · Support, Patient Position2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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