SUNMED LLC
Received Jul 7, 2023 · Event occurred Feb 17, 2023
Report 1314417-2023-00018 · MDR key 17279423
Device
Generic name
Sm Adult Airflow Resus Bag
Manufacturer
Sunmed Holdings LlcModel number
AF5040MBCatalog number
AF5040MB
Lot number
21300279
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Unknown
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
FACE MASKS INSIDE THE KIT ARE FLAT(UNDERINFLATED).
Additional Manufacturer Narrative
THE MASK DEFLATING AND NOT PROPERLY SEALING TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PUT THEM AT RISK. 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.
Description of Event or Problem
FACE MASKS INSIDE THE KIT ARE FLAT (UNDERINFLATED).
Additional Manufacturer Narrative
THE MASK DEFLATING AND NOT PROPERLY SEALING TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PUT THEM AT RISK.