MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH TRULED HANDLE CARTRIDGE, MEDIUM; LARYNGOSCOPE, RIGID

Catalog Number 42143100T

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the laryngoscope didn't charge and was unable to be used in the emergency room.No patient harm was reported.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation.The manufacturer reports the device history record was reviewed for lot no.1607v3 and no issues that could have contributed to the reported failure were noted.The device was manufactured according to release specification.The manufacturer also reports that it has been identified that the product was manufactured in july 2016 and the product shelf life has exceeded the committed warranty months at the time of complaint reporting.

Event Description

Customer complaint alleges the laryngoscope didn't charge and was unable to be used in the emergency room.No patient harm was reported.

• Brand Name: RUSCH TRULED HANDLE CARTRIDGE, MEDIUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TRUPHATEK INTERNATIONAL LTD.; netanya
• MDR Report Key: 9522163
• MDR Text Key: 189448616
• Report Number: 8030121-2019-00116
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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: 42143100T
• Device Lot Number: 1607V3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.