RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-04-26 for RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502 manufactured by Teleflex Medical.

Event Text Entries

[43686901] (b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


[43686902] The customer alleges that the unit failed. One battery emitted smoke.
Patient Sequence No: 1, Text Type: D, B5


[44724198] (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.
Patient Sequence No: 1, Text Type: N, H10


[44724199] The customer alleges that the unit failed. One battery emitted smoke.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2016-00084
MDR Report Key5609178
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2016-04-26
Date of Report2016-04-11
Date of Event2016-04-11
Date Mfgr Received2016-05-06
Date Added to Maude2016-04-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUSCH TRULED ADULT RECHARGEABLE BATTERY
Generic NameBATTERY, RECHARGEABLE
Product CodeFCO
Date Received2016-04-26
Returned To Mfg2016-04-20
Catalog Number0055502
Lot NumberUNKNOWN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-26

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