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

Catalog Number 0055502

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has been received by the manufacturer, however the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer alleges the device is not charging properly.Usage of the device at the time of the alleged malfunction is unknown.There was no report of patient involvement.

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The device was received and it was found to be beyond the life expectancy, which is 18 months.The device is out of warranty; therefore, the complaint could not be confirmed.

Event Description

Customer alleges the device is not charging properly.Usage of the device at the time of the alleged malfunction is unknown.There was no report of patient involvement.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6848938
• MDR Text Key: 85353007
• Report Number: 8030121-2017-00125
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

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: 1451V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 09/29/2017
• 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: Unknown
• Patient Sequence Number: 1