MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/MASK & PEEP V; MANUAL EMERGENCY RESUSCITATOR

Catalog Number 5374

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch# (b)(4).The manufacturing and inspection records in the past year were reviewed and there were no related issues found.Based on the limited information (no sample, no photo), this case is considered to be caused by leaking normally during storage (or transportation) and it is a single reported case.

Event Description

The customer alleges that while applying the ambu mask, the mask was unable to hold air and conform to the patient's face.Another device was used without issue.No patient harm reported.

• Brand Name: HUDSON DISP MANUAL RESUS,ADULT W/MASK & PEEP V
• 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: 5563227
• MDR Text Key: 42182873
• Report Number: 3011137372-2016-00073
• 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: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5374
• Device Lot Number: 1530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2016
• 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
• Patient Age: 65 YR