SUNMED LLC
Received Jun 21, 2023 · Event occurred May 15, 2023
Report 1314417-2023-00015 · MDR key 17175394
Device
Generic name
Adult Airflow Resus W/manomete
Manufacturer
Sunmed Holdings LlcModel number
AF1140MBCatalog number
AF1140MB
Lot number
319663,2008052,2102083,392424
Product problems
- Deflation Problem
- Deflation Problem
Patient
Unknown
- Hypoxia
- Hypoxia
Narrative
Description of Event or Problem
MASKS ARE DEFLATED AND WILL NOT PROPERLY SEAL ON PATIENTS FACE. CUSTOMER STATED THE FOLLOWING: THIS ISSUE IS PLACING OUR PATIENTS AT GREAT RISK IN THE EVENT A CODE BLUE IS CALLED, THE MASK WILL NOT PROPERLY SEAL ON THE PATIENTS FACE.
Additional Manufacturer Narrative
THE POTENTIAL TO PUT THE PATIENT AT RISK IF NOT CHECKED BEFORE STOCKING BY THE PATIENT'S BEDSIDE. SUMMARY: COMPLAINT CONFIRMED VIA RETURNED DEVICES. THE MASKS ARE ABLE TO BE INFLATED AND USED PROPERLY. THE CUSTOMER WAS NOTIFIED OF POTENTIAL CAUSES FOR DEFLATED MASKS. RA: INSTRUCTIONS FOR MASK USE IN COMBINATION WITH RMA-20020 ARE SUFFICIENT RISK ANALYSIS FOR THE REPORTED PRODUCT COMPLAINT.
Additional Manufacturer Narrative
THE POTENTIAL TO PUT THE PATIENT AT RISK IF NOT CHECKED BEFORE STOCKING BY THE PATIENT'S BEDSIDE.
Description of Event or Problem
MASKS ARE DEFLATED AND WILL NOT PROPERLY SEAL ON PATIENTS FACE. CUSTOMER STATED THE FOLLOWING: THIS ISSUE IS PLACING OUR PATIENTS AT GREAT RISK IN THE EVENT A CODE BLUE IS CALLED, THE MASK WILL NOT PROPERLY SEAL ON THE PATIENTS FACE.