MAUDE Adverse Event Report: AMBU A/S SPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 544200047

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2017

Event Type  malfunction  

Event Description

Two broken ambu bags were found in the operating room space.The ambu bags appear to have broken where the valve attaches to the bag.

• Brand Name: SPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; sanjay parikh; 6230 old dobbin ln ste 250; columbia MD 21045
• MDR Report Key: 6913976
• MDR Text Key: 88157623
• Report Number: 6913976
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 544200047
• Device Catalogue Number: 544200047
• Device Lot Number: 1861681
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1