MAUDE Adverse Event Report: NIHON KOHDEN AMERICA INC. NIHON KOHDEN TELEMETRY PACK BATTERY; TRANSMITTER

Device Problems Overheating of Device (1437); Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 at 23:00, the telemetry pack became hot, when the nurse removed to investigate, one of the batteries (procell aa 1.5v lr6 pc1500) had began to peel.The telemetry pack was removed and taken out of service.Dates of use: (b)(6) 2018, diagnosis or reason for use: elevated troponin."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: NIHON KOHDEN TELEMETRY PACK BATTERY
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN AMERICA INC.
• MDR Report Key: 7596256
• MDR Text Key: 111193627
• Report Number: MW5077817
• Device Sequence Number: 2
• Product Code: GWL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 104