PORTEX 1ST RESPONSE MANUAL RESUSCITATOR
Received Mar 1, 2023 · Event occurred Sep 23, 2022
Report 3012307300-2023-01824 · MDR key 16461321
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Smiths Medical Asd, Inc.Catalog number
8520BM
Lot number
181203
Product problems
- Failure to Deliver
- Failure to Deliver
Patient
Unknown
- Low Oxygen Saturation
- Decreased Respiratory Rate
- Respiratory Insufficiency
- Low Oxygen Saturation
- Decreased Respiratory Rate
- Respiratory Insufficiency
Narrative
Additional Manufacturer Narrative
UDI IS UNKNOWN, NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. EXPIRATION DATE AND MANUFACTURE DATE ARE UNKNOWN. NO INFORMATION IS AVAILABLE BASED ON REPORTED LOT NUMBER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT A MEDICAL TEAM USED MATERIAL WITH THE CORRECT TECHNIQUE AND ADEQUATE FACE MASK SIZE, HOWEVER, THE VENTILATION MANEUVER WAS INADEQUATE, AS THE BAG DID NOT GENERATE ENOUGH PRESSURE AND THE CHILD'S CHEST DID NOT EXPAND AND DID NOT RECOVER SPO2.
Additional Manufacturer Narrative
NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING DEVICE HISTORY RECORDS FOUND NO DISCREPANCIES OR ANOMALIES. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO ACTIONS HAVE BEEN TAKEN AT THIS TIME.