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

Model Number 521611000

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2022

Event Type  Death  

Manufacturer Narrative

The suspected failure was detected during the use of the resuscitator.Neither a sample or a picture was received to evaluate suspected failure.The reported product was manufactured and controlled in accordance with the working instructions.100% function test after assembly and 100% visual inspection is conducted on all spur ii devices before being delivered to user.The incident should not be possible when the instructions for use is followed correctly.The resuscitator is designed so that the outlet connector can be screwed off and the patient valve can be cleaned.It is most likely that the resuscitator was not properly reassembled after such cleaning.Due to the limited information available a root cause cannot be identified.The complaint rate is assessed to be acceptably low during the last 12 months and customer has checked all other stocks in the hospital and did not see more like this.According to the instructions for use the described failure can easily be detected during precheck.It seems most likely to be caused by user mishandling.Since no design or manufacturing problem is identified, corrective actions is not required.Device was requested, if device returned for investigation, and new information warranted, we will submit follow up report.Ambu will keep monitoring this issue and take actions if necessary.

Event Description

The customer has reported that a flutter valve was missing from a spur ii.The patient on which the product was used unfortunately died.

• Brand Name: AMBU SPUR II ADULT RESUSCITATOR
• Type of Device: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 13525653
• MDR Text Key: 285562320
• Report Number: 1220828-2022-00003
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 00570748001735
• UDI-Public: 0570748001735
• 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: 01/18/2022,02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 521611000
• Device Lot Number: 1000527568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death