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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER VENTILATOR, EMERGENCY, MANUAL Back to Search Results
Catalog Number 5372
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that there was a hole on the cushion along the edge of hard shell and just little air left in the air cushion, when it was received. The sample was then immersed in water and the air cushion was pressed. No bubbles were observed indicating there were no leaks. Based on the investigation performed the reported complaint was confirmed. It was determined that the mask was pressed by out force during transportation that caused the damage and air leaked.
 
Event Description
Customer complaint alleges "we went to use the item for an emergency and the whole mask was deflated and not functioning". There was no report of patient harm.
 
Manufacturer Narrative
(b)(4). The investigation into this complaint is still in progress. The device involved has not been received by the manufacturer at the time of this report.
 
Event Description
Customer complaint alleges "we went to use the item for an emergency and the whole mask was deflated and not functioning". There was no report of patient harm.
 
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Brand NameHUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7174852
MDR Text Key279090672
Report Number3011137372-2018-00014
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964719
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/08/2019
Device Catalogue Number5372
Device Lot Number160808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
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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