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

Catalog Number 5372

Device Problem Inflation Problem (1310)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are incomplete at the time of this report.

Event Description

The customer alleges that the air cushion mask on the adult resuscitation bag was found deflated prior to use on a patient that needed assistance breathing.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed on lot number 1404 and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the air cushion mask on the adult resuscitation bag was found deflated prior to use on a patient that need ed assistance breathing.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5463155
• MDR Text Key: 39487374
• Report Number: 3011137372-2016-00044
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• 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: 1404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• 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