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

Model Number 521611000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2022

Event Type  malfunction  

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.

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 assesed 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.The risk has been evaluated in the product risk evaluation and it's concluded as acceptable.It seems most likely to be caused by user mishandling.Since no design or manufacturing problem is identified, corrective actions is not required.Ambu will keep monitoring this issue and take actions if necessary.

• Brand Name: AMBU SPUR II ADULT RESUSCITATOR
• Type of Device: MANUAL EMERGENCY VENTILATOR
• 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: lena søndergaard ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 13505813
• MDR Text Key: 288099478
• Report Number: 9610691-2022-00002
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 00570748001735
• UDI-Public: 0570748001735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 521611000
• Device Lot Number: 1000527568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death