MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH TRULED ADULT RECHARGEABLE BATTERY; LARYNGOSCOPE, RIGID

Catalog Number 0055502

Device Problem Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for investigation.Upon receipt the truled battery/led cartridge was visually examined for any signs of abus e/misuse/damage.None were noted other than normal wear and tear due to day to day activity.The battery/led cartridge was connected to a known good truled charging unit.The unit remained in the charging unit for well over 12 hours.The red charging light never changed to a green status.The complaint has been confirmed.The complaint has been confirmed.However, root cause cannot be determined.The warranty period is 18 months.Expiration date code for this unit is 1536.It should be mentioned the unit has passed the expiration date code by approximately 6 months.While the root cause for the charging failure cannot be definitively established, speculatively the charging circuitry could have been subjected to some form of trauma, or a circuit component could be faulty.No further action is required.

Event Description

Customer complaint alleges the battery is not holding a charge.Alleged issue is reported as detected during pre-testing, prior to use.No report of patient involvement.No report of patient harm or delay in treatment.

• Brand Name: RUSCH TRULED ADULT RECHARGEABLE BATTERY
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TRUPHATEK INTERNATIONAL LTD.; netanya
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6588245
• MDR Text Key: 75871041
• Report Number: 8030121-2017-00077
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0055502
• Device Lot Number: 1536V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/24/2017
• 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: Reuse
• Patient Sequence Number: 1