MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II ADULT BAG RES; MANUAL EMERGENCY VENTILATOR

Model Number 520211000

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 10/30/2021

Event Type  Injury  

Event Description

Per maude report: patient was in dialysis receiving her first intermittent hemodialysis run and an hour into her run, went unresponsive.Patient started desaturating, close face mask applied at "flush" rate.Patient still unable to maintain good saturations.Emergency ambu bag that was in room was accessed and hooked up to oxygen, applied over mouth, however the patient continued to desaturate despite attempting manual breaths and being hooked up to the oxygen through ambu bag tubing.Patient placed back onto closed face mask and rrt arrived at bedside.Ambu bag was hooked up to another oxygen tree in another room to assess quality and function and was found to be malfunctioned, not allowing any air through the mask.

Manufacturer Narrative

No sample was returned for investigation, nor was a lot number provided.It was not possible to verify the reported failure as no sample was available for investigation, further there is limited information on the reported failure to assist in the investigation.Hence, a root cause cannot be identified.Based on description of event, we infer that the incident may be due to insufficient ventilation that caused the patient unable to maintain good saturation.The possible cause of insufficient ventilation may be due to patient valve disc or inlet valve disc missing or malfunction.However, as no sample has been returned and due to limited information, the reported failure and root cause cannot be determined.Ambu will keep monitoring it and take actions if necessary.

• Brand Name: AMBU SPUR II ADULT BAG RES
• Type of Device: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 13026289
• MDR Text Key: 284135082
• Report Number: 1220828-2021-00021
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 05707480032747
• UDI-Public: 05707480032747
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021,12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 520211000
• Device Catalogue Number: 520211000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention