MAUDE Adverse Event Report: AMBU A/S SPUR® II PEDIATRIC RESUSCITATORW/MANOMETER PEEP VALVE 20; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 530613031

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Brought the patient off of ecmo and some resuscitation was needed.No chest rise and then switched out to a new bag that improved ventilation.Manufacturer response for ambu bag, (brand not provided) (per site reporter).The manufacturer is still in the process of figuring out what made the bag fail.We should have some information within few days from the manufacturer.

• Brand Name: SPUR® II PEDIATRIC RESUSCITATORW/MANOMETER PEEP VALVE 20
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU A/S; 6230 old dobbin ln ste 250; columbia MD 21045
• MDR Report Key: 11811667
• MDR Text Key: 250186168
• Report Number: 11811667
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 530613031
• Device Catalogue Number: 530613031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1