PORTEX GENERAL ANESTHESIA BAG
Received Jan 19, 2024 · Event occurred Dec 1, 2023
Report 9617604-2024-00062 · MDR key 18544389
Device
Generic name
Bag, Reservoir
Manufacturer
Smiths Healthcare Mfr S.a. De C.v.Catalog number
670002
Lot number
UNKNOWN
Product problems
- Device Damaged Prior to Use
- Device Damaged Prior to Use
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE BROKEN BAG WAS CONFIRMED.. ROOT CAUSE WAS NOT ESTABLISHED. THIS ISSUE WILL CONTINUE TO BE MONITORED AND FURTHER ACTIONS TAKEN ACCORDINGLY.
Additional Manufacturer Narrative
B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. REPORTER PHONE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT THE BAG WAS DAMAGED AND CONFIRMED TO BE DAMAGED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.