MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 1ST RESPONSE ADULT MANUAL RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number 8503

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

The patient was coding and the staff grabbed the closed package of the ambu bag and mask off the code cart and opened the package.The package that was supposed to contain the mask and bag was missing the mask.Another set up was available on the cart and there was no delay in providing care to the patient.

• Brand Name: 1ST RESPONSE ADULT MANUAL RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; us agent: cynthia englehardt; 10 bowman; keene NH 03431
• MDR Report Key: 5920468
• MDR Text Key: 53726606
• Report Number: 5920468
• 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: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 8503
• Device Lot Number: 141231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2016
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; OTHER
• Patient Age: 57 YR
• Patient Weight: 86