SUNMED LLC
Received Apr 1, 2022 · Event occurred Jan 18, 2022
Report 1314417-2022-00011 · MDR key 13972930
Device
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A BROKEN DEVICE DELAYED THEIR RESUSCITATION EFFORTS.
Description of Event or Problem
STAFF GETTING AMBU (RESUSCITATION) BAG READY FOR INTUBATION AND DEVICE BROKE.
Additional Manufacturer Narrative
A BROKEN DEVICE DELAYED THEIR RESUSCITATION EFFORTS. NO PRODUCT RETURNED, NO FURTHER EXPLANATION OF DEVICE FAILURE. CUSTOMER CONTACT MADE REQUESTING ADDITIONAL INFORMATION AND NONE COULD BE PROVIDED. CUSTOMER ACKNOWLEDGED THAT FURTHER INVESTIGATION COULD NOT BE COMPLETED WITHOUT ADDITIONAL INFORMATION. RA: RMA-20020 R37 "DEVICE CANNOT PERFORM AS INTENDED" IDENTIFIES POTENTIAL BROKEN RESUSCITATION BAGS NOT ABLE TO PERFORM AS INTENDED. NO UPDATE TO RMA REQUIRED.
Description of Event or Problem
STAFF GETTING AMBU (RESUSCITATION) BAG READY FOR INTUBATION AND DEVICE BROKE.