VENTLAB
Received Nov 3, 2023 · Event occurred Oct 4, 2023
Report 1314417-2023-00025 · MDR key 18068626
Device
Generic name
Airflow Adult Resuscitator With Integrated Manometer, B/v Filter, Bag Reservoir,
Manufacturer
Sunmed Holdings LlcModel number
AF5140MBPCatalog number
AF5140MBP
Lot number
426087
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
NA · Unknown
- Respiratory Insufficiency
- Respiratory Insufficiency
Narrative
Description of Event or Problem
WHEN BAG WAS SQUEEZED NO AIR WAS BEING DELIVERED TO THE PATIENT. PATIENT STATS DROPPED RAPIDLY, RECOVERED FAST AFTER SWITCHING THE BAG. AMBU WAS NOT FUNCTIONING PROPERLY. AMBU WAS BEING SQUEEZED, NUT NO CHEST RISE VOLUME NOT BEING DELIVERED TO PT DESPITE ORAL AIRWAY IN PLACE AND A GOOD SEAL ON A MASK ON PT'S FACE. PT WAS BEING INTUBATED AND PT'S DESATED TO 74%, UNTIL A NEW AMBU WAS GRABBED FROM ANOTHER ROOM AND PT'S SATS INCREASED INTO THE 90'S AND PT WAS SUCCESSFULLY INTUBATED. OLD AMBU AND BAG OBTAINED FROM ROOM PULLED
Additional Manufacturer Narrative
THE BAG NOT PROVIDING OXYGEN WHILE SQUEEZING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED.
Description of Event or Problem
WHEN BAG WAS SQUEEZED NO AIR WAS BEING DELIVERED TO THE PATIENT. PATIENT STATS DROPPED RAPIDLY, RECOVERED FAST AFTER SWITCHING THE BAG. AMBU WAS NOT FUNCTIONING PROPERLY. AMBU WAS BEING SQUEEZED, NUT NO CHEST RISE VOLUME NOT BEING DELIVERED TO PT DESPITE ORAL AIRWAY IN PLACE AND A GOOD SEAL ON A MASK ON PT'S FACE. PT WAS BEING INTUBATED AND PT'S DESATED TO 74%, UNTIL A NEW AMBU WAS GRABBED FROM ANOTHER ROOM AND PT'S SATS INCREASED INTO THE 90'S AND PT WAS SUCCESSFULLY INTUBATED. OLD AMBU AND BAG OBTAINED FROM ROOM PULLED
Additional Manufacturer Narrative
THE BAG NOT PROVIDING OXYGEN WHILE SQUEEZING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED. SUMMARY: RETURNED PRODUCT INVESTIGATED AND FOUND TO BE IN WORKING ORDER. NO FURTHER INVESTIGATION REQUIRED. NO APPLICABLE RISK ASSOCIATED WITH CONFORMING PRODUCT. **UDI RELATED DATA QUALITY UPDATES ONLY**
Additional Manufacturer Narrative
THE BAG NOT PROVIDING OXYGEN WHILE SQUEEZING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED. SUMMARY: RETURNED PRODUCT INVESTIGATED AND FOUND TO BE IN WORKING ORDER. NO FURTHER INVESTIGATION REQUIRED. NO APPLICABLE RISK ASSOCIATED WITH CONFORMING PRODUCT.
Description of Event or Problem
WHEN BAG WAS SQUEEZED NO AIR WAS BEING DELIVERED TO THE PATIENT. PATIENT STATS DROPPED RAPIDLY, RECOVERED FAST AFTER SWITCHING THE BAG. AMBU WAS NOT FUNCTIONING PROPERLY. AMBU WAS BEING SQUEEZED, NUT NO CHEST RISE VOLUME NOT BEING DELIVERED TO PT DESPITE ORAL AIRWAY IN PLACE AND A GOOD SEAL ON A MASK ON PT'S FACE. PT WAS BEING INTUBATED AND PT'S DESATED TO 74%, UNTIL A NEW AMBU WAS GRABBED FROM ANOTHER ROOM AND PT'S SATS INCREASED INTO THE 90'S AND PT WAS SUCCESSFULLY INTUBATED. OLD AMBU AND BAG OBTAINED FROM ROOM PULLED.