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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH TRULED ADULT RECHARGEABLE BATTERY; LARYNGOSCOPE, RIGID
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TRUPHATEK INTERNATIONAL LTD. RUSCH TRULED ADULT RECHARGEABLE BATTERY; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 0055502
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the bulb and battery filament inside the handle was broken.The device would not light up.It was reported that "when you look inside the bulb you can see the filament inside the bulb is not connected or you can see a break in the filament".No other physical damage was observed.The reported issue was discovered during set up and a different device was obtained for use.
 
Event Description
Customer reported the bulb and battery filament inside the handle was broken.The device would not light up.It was reported that "when you look inside the bulb you can see the filament inside the bulb is not connected or you can see a break in the filament".No other physical damage was observed.The reported issue was discovered during set up and a different device was obtained for use.
 
Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturer (truphatek, india).The manufacturer reports the sample was found to be "non-functional, no light output during charging.It seems soldering joint connection between rechargeable battery and led is broken or dismantle inside cartridge.It is difficult to comment on mechanism of joint breakage, it could be unfavourable external vibration or impact during transportation.Battery is fine and charging but there is no light output." the device history record of lot 190301 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 investigation performed, the complaint was confirmed.The cartridge was found to be defective with the soldered joint broken inside.The root cause was identified as manufacturing related.The manufacturer reports this product was discontinued after dec 2019.There would be no future supplies or manufacturing.
 
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Brand Name
RUSCH TRULED ADULT RECHARGEABLE BATTERY
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TRUPHATEK INTERNATIONAL LTD.
netanya
MDR Report Key9474239
MDR Text Key189450135
Report Number8030121-2019-00114
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 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0055502
Device Lot Number190301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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