MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; MANUAL EMERGENCY RESUSCITATOR

Catalog Number 5372

Device Problem No Flow (2991)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation.Manufacturing and inspection records in the past years were reviewed and there were no related issues found.Based on the limited information (no sample, no photo), this case was considered a single case.

Event Description

The maude adverse event report indicates that the manual resuscitation bag attached to the endotracheal tube would allow for inhalation but not for exhalation.A new manual resuscitation bag was obtained and was noted to function properly.

• Brand Name: HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
• Type of Device: MANUAL EMERGENCY RESUSCITATOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5583986
• MDR Text Key: 42873381
• Report Number: 3011137372-2016-00083
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5372
• Device Lot Number: 1443
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOTRACHEAL TUBE