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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AIR CUSHION MASK W/VALVE,LARGE ADULT VENTILATOR, EMERGENCY, MANUAL

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TELEFLEX MEDICAL HUDSON AIR CUSHION MASK W/VALVE,LARGE ADULT VENTILATOR, EMERGENCY, MANUAL Back to Search Results
Catalog Number 1282
Device Problems Device Damaged Prior to Use (2284); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device sample was received for evaluation. A device history record review showed no issues that could be related to this complaint. The complaint has been confirmed. During testing a very definitive leak was discovered in the facial mask plastic and was later confirmed under magnification as a cut or tear. The length of the cut/tear is less than one 1/32 inch. The cut/tear edges are very smooth indicating at some point the mask might have come in contact with a sharp object. The root cause cannot be established. No corrective action can be assigned. Teleflex will continue to monitor customer feedback for complaints of this nature.
 
Event Description
Customer complaint alleges the device mask presented a leak in the cushion. Alleged defect reported detected prior to use on a patient. No patient harm reported.
 
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Brand NameHUDSON AIR CUSHION MASK W/VALVE,LARGE ADULT
Type of DeviceVENTILATOR, EMERGENCY, MANUAL
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
linda woodall
3015 carrington mill blvd
morrisville 27560
9196942566
MDR Report Key7860752
MDR Text Key119792647
Report Number3011137372-2018-00246
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 08/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1282
Device Lot Number171104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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