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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS; MANUAL RESUSCITATION BAG
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TELEFLEX MEDICAL HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS; MANUAL RESUSCITATION BAG Back to Search Results
Catalog Number 5346
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "connector loose before patient contact." no patient involvement.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "connector loose before patient contact." no patient involvement.
 
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Brand Name
HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MAS
Type of Device
MANUAL RESUSCITATION BAG
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8684818
MDR Text Key147577248
Report Number3011137372-2019-00176
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
K895589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date09/29/2021
Device Catalogue Number5346
Device Lot Number160929
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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