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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551004
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the light pipe broke during use.The patient was in cardiac arrest from a fentanyl overdose.The staff obtained a crash cart and the device to intubate the patient.The plastic light pipe near the connector area to the handle was broken and the light would not turn on.A new device was obtained from the cart and the same issue happened.The patient was intubated with a glidescope.It was reported the patient did not suffer any injury from the device.The patient was reported to be in icu from other medical complications at the time of this report.
 
Event Description
Customer reported the light pipe broke during use.The patient was in cardiac arrest from a fentanyl overdose.The staff obtained a crash cart and the device to intubate the patient.The plastic light pipe near the connector area to the handle was broken and the light would not turn on.A new device was obtained from the cart and the same issue happened.The patient was intubated with a glidescope.It was reported the patient did not suffer any injury from the device.The patient was reported to be in icu from other medical complications at the time of this report.
 
Manufacturer Narrative
(b)(4).The sample was not returned; however, the customer provided a photo for evaluation.The manufacturing site reports that based on the photo the complaint is confirmed.The base of the light guide is broken.The manufacturer also reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.Due to an increase in complaints for breakage, a capa was opened to further investigate this issue.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9857095
MDR Text Key189442801
Report Number8030121-2020-00042
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,user f
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number004551004
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GLIDESCOPE; GLIDESCOPE
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