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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC BATTERY; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC BATTERY; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 005853300
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer complaint alleges the battery does not work.Alleged issue reported as detected during pre-testing prior to use.There was no patient involvement reported.
 
Manufacturer Narrative
(b)(6).Complaint verification testing could not be performed as no sample was returned for analysis.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.
 
Event Description
Customer complaint alleges the battery does not work.Alleged issue reported as detected during pre-testing prior to use.There was no patient involvement reported.
 
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Brand Name
RUSCH MRI COND FIBER OPTIC BATTERY
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8213216
MDR Text Key132216835
Report Number8030121-2019-00001
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number005853300
Device Lot Number153202
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received01/03/2019
Supplement Dates Manufacturer Received01/23/2019
Supplement Dates FDA Received01/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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