MAUDE Adverse Event Report: AMBU A/S SPUR II ADULT FOR DEMAND VALVE; MANUAL RESUSCITATOR

Catalog Number 325023000

Device Problems Connection Problem (2900); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Two affected devices were returned to the manufacturer for investigation.The reported failure was verified by visual inspection of the devices.Production and qc reccords for the applicable lots were checked.No abnormalities where noted.Hence, the spur ii resuscitators were in good state when leaving the factory.The most likely root cause of the deformation is long time storage in a compressed state with tight connection of oxygen nipple and oxygen tube.The reported issue is easily identifiable during the prescribed precheck of the device prior to use on patient.

Event Description

Oxygen flow via tubing from the oxygen wall connection into the reservoir bag of the spur ii was not possible because the connection point on the reservoir bag was bent, fused and internally tight.After identifying the problem, all sets were reviewed in the or and several reservoir bags with the same problem were identified and replaced.The patient condition was not affected.While one faulty device does not pose a risk of serious health deterioration as the spur ii will still be able to provide resuscitation with ambient air (21% oxygen) until a back up resuscitator has ben readied for use, the patient is at risk of hypoxia when the back up device also fails to deliver high oxygen concentration.

• Brand Name: SPUR II ADULT FOR DEMAND VALVE
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 12162764
• MDR Text Key: 263461008
• Report Number: 1220828-2021-00012
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/13/2021

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 Operator: Health Professional
• Device Catalogue Number: 325023000
• Device Lot Number: 1927634, 1883919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1