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

Catalog Number 520211000

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This mdr is resubmitted as it was discovered that this mdr has not been successfully loaded into fdas database.The initial reporting to fda of this case has been done to fda within the original deadline, however in the wrong file format to support correct upload.This submission represents a reload of data to ensure correct upload to the fda database.As device was not returned from customer, the reported issue cannot be identified.The reported face mask was packed by according to packing procedure and packed in a plastic bag.The mask was made up of dome and cushion, which were combined with glue.A part that can break off from the mask and be swallowed can't be identified from review of similar products or from packaging.For the last 3 years, no complaints with a similar issue has been reported for the spur ii or face mask products.

Event Description

An inmate at a prison needed to be resuscitated and the ambu mask (part of the spur ii kit) was used.The customer reported that a piece of the mask broke off and was swallowed by the inmate.The inmate was in critical condition and the customer inferred it was probably due to the mask.

• Brand Name: AMBU SPUR II
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12108131
• MDR Text Key: 262202279
• Report Number: 9610691-2019-00011
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 520211000
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Life Threatening