Synclara Cough System M08086Recalls & reported problems
Hill-Rom Services Pte. Ltd. · Respiratory Care · Class 2
- 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 00887761995062), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Crack
ON 18-DEC-2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM SERVICE, NON-FT SW, HC, NA (PRODUCT CODE M08575A, SERIAL NUMBER (B)(6)), HAD BIOFILTER CRACKED WHERE IT CONNECTS TO THE DEVICE. THE BIOFILTER WAS DISPOSED OF BY HUSBAND. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23989775 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.