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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH RUSCH MRI HANDLE BATTERIES PACK OF 1; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH RUSCH MRI HANDLE BATTERIES PACK OF 1; LARYNGOSCOPE, RIGID Back to Search Results
Model Number IPN048614
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported "anesthesia member went to use mri kit purchased in 2020.Battery was dead- light did not come on laryngoscope when engaged.Tried multiple times.Changed batteries and same effect".No patient involvement reported.
 
Event Description
It was reported "anesthesia member went to use mri kit purchased in 2020.Battery was dead- light did not come on laryngoscope when engaged.Tried multiple times.Changed batteries and same effect".No patient involvement reported.
 
Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
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Brand Name
RUSCH RUSCH MRI HANDLE BATTERIES PACK OF 1
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key11641336
MDR Text Key244640590
Report Number8030121-2021-00014
Device Sequence Number1
Product Code CCW
UDI-Device Identifier14026704616272
UDI-Public14026704616272
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN048614
Device Catalogue Number005853300
Device Lot Number124202
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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