MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number 0000943560

Device Problem Component Missing (2306)

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

Event Date 03/08/2017

Event Type  malfunction  

Event Description

During rounding the hallways, i was opening the o2 tubing to prepare for the stretchers and found a package that was missing the peep valve.We took the tubing and wrapping and gave it to manager.Manufacturer response: for inflating resuscitation device with peep valve, (brand not provided) (per site reporter) requested to mail to rep home so he could file complaint.

• Brand Name: AIRLIFE
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 n fairway dr.; vernon hills IL 60061
• MDR Report Key: 6463431
• MDR Text Key: 71878811
• Report Number: 6463431
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0000943560
• Device Lot Number: 10885403293931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1