MAUDE Adverse Event Report: AMBU INC. SPUR II PEDIATRIC RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL

Catalog Number 530213011

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

Baby required intubation due to severe tachypnea and retractions.Prior to intubation the procedure is to oxygenate with 100% o2 with ambu bag.The respiratory therapist (rt) grabbed the ambu bag in room and attempted to bag, but the bag seemed to be malfunctioning; it was easy to squeeze with no chest rise.On "override" it sounded as if the bag had a leak.Another positive pressure ventilation (ppv) bag was obtained and functioned properly.The baby then successfully intubated.

• Brand Name: SPUR II PEDIATRIC RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL
• Manufacturer (Section D): AMBU INC.; 6230 old dobbin ln ste 250; columbia MD 21045
• MDR Report Key: 7320159
• MDR Text Key: 101785294
• Report Number: 7320159
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 530213011
• Other Device ID Number: LOT # OF STOCK: 1980223; UNCL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• 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
• Treatment: NO; NOT APPLICABLE.
• Patient Weight: 6