SUNMED HOLDINGS LLC
Received Mar 30, 2022 · Event occurred Feb 28, 2022
Report 1314417-2022-00010 · MDR key 13955199
Device
Generic name
Small Adult Resus Bag W/mask And Bag Reservoir
Manufacturer
Sunmed LlcModel number
AF5000MBProduct problems
- Gas/Air Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LEAKING EXHALATION VALVE.
Additional Manufacturer Narrative
REPORTABLE LEAK COULD POTENTIALLY LOWERED VOLUME DELIVERED TO PATIENT.
Additional Manufacturer Narrative
REPORTABLE LEAK COULD POTENTIALLY LOWERED VOLUME DELIVERED TO PATIENT. THIS ISSUE HAS BEEN ADDRESSED IN THE FIELD AND THE CUSTOMER IS COMFORTABLE WITH THE PRODUCT. DURING A FIELD VISIT THE CLINICIAN COULDN'T REPRODUCE THE ISSUE AND DIDN'T SAVE THE PRODUCT IN QUESTION. TRISTAR SKYLINE MEDICAL CENTER IS THE CUSTOMER. COULD NOT LOCATE ACCOUNT IN SALESPAD. CUSTOMER COMPLAINED ABOUT DEVICE LEAKING. THE ISSUE COULD NOT BE REPLICATED DURING A FIELD VISIT WITH THE CLINICIAN. NO CUSTOMER ACTION REQUIRED. RA: MULTIPLE HAZARD EFFECTS LISTED IN RMA-20020 FOR FUNCTIONAL ISSUES. COMPLETE INVESTIGATION COULD NOT BE DONE WITHOUT RETURNED PRODUCT OR REPEATED SCENARIO.
Description of Event or Problem
LEAKING EXHALATION VALVE.