The VitalCough®System M06563Recalls & reported problems
Hill-Rom Services Pte. Ltd. · Respiratory Care · Class 2
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 00887761997318), received between Sep 5, 2023 and May 6, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (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.
Reports received per month
Most reported problems
Device problems
- Circuit Failure1
- Material Split, Cut or Torn1
- Sparking1
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.
MalfunctionMay 6, 2024Circuit Failure; Sparking; Circuit Failure; Sparking
BAXTER RECEIVED A REPORT FROM A CUSTOMER STATING THE DEVICE SPARKED AT POINT OF POWER CORD AND DEVICE CONNECTION AND BLEW HOME BREAKER TWICE. 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 19248882 ↗MalfunctionSep 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE POWER CORD WAS FRAYED AND READY TO BREAK; WIRES EXPOSED. 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 17684973 ↗
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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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