WESTMED
Received Apr 21, 2022 · Event occurred Mar 16, 2022
Report 2028807-2022-00013 · MDR key 14172289
Device
Product problems
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
RESUSCITATOR FELL APART DURING USE. THIS WAS AN INTERRUPTION IN RESUSCITATION EFFORTS. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.
Description of Event or Problem
MANUAL RESUSCITATOR FELL APART DURING USE.
Additional Manufacturer Narrative
RESUSCITATOR FELL APART DURING USE. THIS WAS AN INTERRUPTION IN RESUSCITATION EFFORTS. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. DEVICE NOT RETURNED, EMAIL CORRESPONDENCE WITH CUSTOMER POINTS TO PATIENT VALVE DISCONNECTION FROM BAG BODY BEING ROOT CAUSE. THIS IS AN ASSEMBLED DEVICE THAT RELIES ON FRICTION BETWEEN THE BARBED CONNECTORS. EXPLANATION OF FAILURE AND MITIGATION PROVIDED TO CUSTOMER VIA EMAIL. ONLY ONE SIMILAR COMPLAINT, NOT TRENDING AT THIS TIME. RA: (B)(4) RISK ID R23 IDENTIFIES THIS RISK ITEM. NO UPDATE TO RISK MANAGEMENT FILES.
Description of Event or Problem
MANUAL RESUSCITATOR FELL APART DURING USE.