MAUDE Adverse Event Report: AMBU A/S SPUR II PEDI. BAG RESVR; AMBU SPUR II

Device Problem Nonstandard Device (1420)

Patient Problem Anemia (1706)

Event Type  Death  

Manufacturer Narrative

The sample for the leaking manometer was returned to our manufacturing facility for investigation on may 07, 2021.The sample was immediately evaluated by the qa engineer.The following functional tests were completed on the returned sample: high/low pressure test; volume test; 02 concentration test recoil time test.Each of the above tests that we performed identified no failures with the returned sample.The results of all tests were within the product specifications.As described in the ifu, it is important to inspect the resuscitator and perform a brief functional test prior to use and to not use the product if a test for functionality fails.

Event Description

Per customer patient was quickly moved to picu (pediatric intensive care unit) and was in process of decompensating.His hgb was only a bit over 2 so did not have any reserve.Spur ii resuscitator was leaking around manometer port which affected the patient and the patient was decompensating.Back up resuscitator was not available.Information was provided on (b)(6) 2021 that patient expired, customer mentioned that the resuscitator was not the cause of the outcome.

• Brand Name: SPUR II PEDI. BAG RESVR
• Type of Device: AMBU SPUR II
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: thuy duong ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 11841498
• MDR Text Key: 251161329
• Report Number: 9610691-2021-00009
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death