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

Catalog Number 325002000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

The spur ii was returned from customer.The reported fault was verified, and the inlet valve disc was found to have come off inside the inlet valve housing.Testing concluded that the product did not fulfil the specification of delivering >85% oxygen concentration in accordance with en iso 10651-4, particular requirements for operator powered resuscitators.Resuscitation/ventilation with ambient air is still possible and within specifications.Testing has also concluded that the failure can be detected when performing the prescribed functional pre-check per the ifu.

Event Description

The customer reports that the inlet valve had come off in the spur ii and when using the product under a procedure, the oxygen saturation of the patient dropped to 77%.The fault was detected after approximately 45 min and was counteracted by using another oxygen source.Patient condition was not affected by this incident.

• Brand Name: AMBU SPUR II
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 8964801
• MDR Text Key: 156592794
• Report Number: 1220828-2019-00009
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 325002000
• Device Lot Number: 1000160900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2019
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention