PORTEX 1ST RESPONSE MANUAL RESUSCITATOR
Received Jul 8, 2022 · Event occurred Jun 13, 2022
Report 3012307300-2022-13109 · MDR key 14955928
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Smiths Medical Asd, Inc.Catalog number
8500
Lot number
211213
Product problems
- Unintended Deflation
- Unintended Deflation
Patient
Unknown
- Low Oxygen Saturation
- Decreased Respiratory Rate
- Low Oxygen Saturation
- Decreased Respiratory Rate
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS UNABLE TO BE EVALUATED AS IT WAS NOT RETURNED. IF THE DEVICE IS RECEIVED IN THE FUTURE AN EVALUATION WILL BE PERFORMED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED PER A COMPLAINT FORM SUBMITTED BY THE SALES DEPARTMENT THAT A DR. WAS TRYING TO INTUBATE A PATIENT AND HAD EQUIPMENT FAILURE AS WELL AS AN RT ISSUE THAT REQUIRED THEM TO CALL THE RT CHARGE TO THE ROOM. THE AMBU BAGS MASK SEEMED TO BE DEFLATED (NOT THE BAG) AND THE PATIENT WASN'T BEING VENTILATED PROPERLY, WHICH RESULTED IN THE PATIENT DESATURATING TO APPROXIMATELY 48%.