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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 Patient Involvement (2645)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been received by the manufacturer.However, the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the investigation.
 
Event Description
Customer complaint alleges the device mask was found deflated and therefore pulled so they would not be used on a patient.The defect was reported a found prior to patient involvement.It is unclear if the event occurred in the clinical setting.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the cushion was a little deflated.There were no other obvious defect detected.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 leaked naturally during transportation and the long time in storage.
 
Event Description
Customer complaint alleges the device mask was found deflated and therefore pulled so they would not be used on a patient.The defect was reported a found prior to patient involvement.It is unclear if the event occurred in the clinical setting.
 
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Brand Name
HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
Type of Device
VENTILATOR, 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 Key7225562
MDR Text Key98544512
Report Number3011137372-2018-00024
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 health professional,user faci
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
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
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
Patient Sequence Number1
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