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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY BATTERY, RECHARGEABLE

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TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY BATTERY, RECHARGEABLE Back to Search Results
Catalog Number 0055502
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 04/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device sample was not returned for evaluation at the time of this report.
 
Event Description
The customer alleges that the unit failed. One battery emitted smoke.
 
Manufacturer Narrative
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. An attempt was made to charge the cartridge with the charging unit that is shipped in the kit with the handle and led cartridge. The red glowing charging light blinked between glowing red and green. This pattern of blinking indicates a charging discrepancy within the charging circuitry. The cartridge was destructively inspected; no sign of battery corrosion was present. The complaint of the cartridge not charging is either related to the charging circuitry, or the age of the battery. A conclusion could not be chosen as the complaint was confirmed; however, a root cause was not established.
 
Event Description
The customer alleges that the unit failed. One battery emitted smoke.
 
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Brand NameRUSCH TRULED ADULT RECHARGEABLE BATTERY
Type of DeviceBATTERY, RECHARGEABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5609178
MDR Text Key43686901
Report Number3011137372-2016-00084
Device Sequence Number1
Product Code FCO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0055502
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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