MAUDE Adverse Event Report: AMBU INC. 4900320000-2017-8036; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/30/2017

Event Type  malfunction  

Event Description

Ambu bag not performing correctly - all connections and lines secure and cross checked.

• Brand Name: 4900320000-2017-8036
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU INC.; 6230 old dobbin ln.; ste. 250; columbia MD 21045
• MDR Report Key: 6739960
• MDR Text Key: 80915604
• Report Number: 6739960
• Device Sequence Number: 0
• 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: 07/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2017
• 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