NIBP Cuffs Single Care Cuff, AdultRecalls & reported problems
Philips Medical Systems Hsg · Single Care Cuff, Adult (navy blue). Single Patient. Circumference 27.5 - 36.0 cm. 20 cuffs per box. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884838037544), received between May 8, 2019 and May 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
Device problems
- Burst Container or Vessel1
- Material Puncture/Hole1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2019Burst Container or Vessel; Material Puncture/Hole
THE CUSTOMER STATED THAT THE BLOOD PRESSURE CUFF "POPPED" OR " EXPLODED". THE BP CUFF WAS NOTED TO HAVE A 2CM HOLE NEAR THE CREASE SIDE (NOT THE SEAM SIDE) WHERE IT POPPED. NEAR TO WHERE THE ARROW AND LABEL " ARTERIA" ARE LOCATED. THERE WAS NO REPORTED PATIENT INCIDENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8590437 ↗
Other Antimicrobial blood pressure cuff devices
- NIBP Cuffs EASY CARE CUFF, 1 HOSE, ADULT (1)Philips Medical Systems Hsg · Antimicrobial blood pressure cuff4 reports
- NIBP Cuffs EASY CARE CUFF, 1 HOSE, ADULT XL (1)Philips Medical Systems Hsg · Antimicrobial blood pressure cuff1 death1 report
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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