MEDLINE
Received Feb 1, 2024 · Event occurred Aug 25, 2023
Report 1314417-2024-00009 · MDR key 18628109
Device
Generic name
Adult Resus W/mask And Bag Reservoir
Manufacturer
Sunmed Holdings LlcModel number
CPRM1116Catalog number
CPRM1116
Lot number
UNKNOWN
Product problems
- Inflation Problem
- Inflation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MANUAL RESUSCITATOR INABILITY TO INFLATE WOULD DELAY THE RESUSCITATION OF PATIENT.
Description of Event or Problem
NOT INFLATING.
Additional Manufacturer Narrative
THE MANUAL RESUSCITATOR INABILITY TO INFLATE WOULD DELAY THE RESUSCITATION OF PATIENT. THE COMPLAINT OF "NOT INFLATING" REGARDING PART CPRM1116 WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF "MFG ERROR - CONNECTION TO SQUEEZE BAG LEAKS". A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN 0 OTHER COMPLAINTS WERE REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS COMPLAINT. NO RESPONSE WAS REQUESTED FROM THE CUSTOMER.
Description of Event or Problem
NOT INFLATING.