MAUDE Adverse Event Report: AMBU, INC. MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number 900000607

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Event Description

Disposable ambu hyperinflation system 1/2 l green bag is consistently separating from white plastic piece that connects the bag to the mask for neonatal resuscitation.No harm to date but has a potential for harm.Noted by staff in the packaging bag when obtaining several of these items; none were useable.

• Brand Name: MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): AMBU, INC.; 6230 old dobbin ln ste 250; columbia MD 21045
• MDR Report Key: 9753217
• MDR Text Key: 180894639
• Report Number: 9753217
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 900000607
• Device Lot Number: 092719N02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2020
• Date Report to Manufacturer: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1