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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 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the laryngoscope light did not come on after changing the battery.It was reported that when the technician compared the new battery to the old battery, it looked different.No patient involvement reported.
 
Manufacturer Narrative
(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
Customer reported the laryngoscope light did not come on after changing the battery.It was reported that when the technician compared the new battery to the old battery, it looked different.No patient involvement reported.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.Upon receipt the mri kit battery was visually examined for any signs of abuse/misuse/damage.Upon visual examination it was noted that the negative end of the battery had been severely damaged by removing part of the battery casing and exposing the entire negative tip end of the mercury cadmium battery.The device history record for lot 190101 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the visual exam, the complaint has been confirmed, however a definitive root cause cannot be assigned as the details of how the incident occurred was not reported.
 
Event Description
Customer reported the laryngoscope light did not come on after changing the battery.It was reported that when the technician compared the new battery to the old battery, it looked different.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 Key9163330
MDR Text Key189455689
Report Number8030121-2019-00094
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,foreig
Type of Report Initial,Followup,Followup
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number005853300
Device Lot Number190101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Date Manufacturer Received04/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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