MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they believe that their transmitter is drawing in too much power from the batteries, which is causing them to overheat and split.The customer was not sure if this issue was discovered during patient use, but they do know for a fact that there was no harm or injury reported.The failed device will be sent in for evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported that they believe that their transmitter is drawing in too much power from the batteries, which is causing them to overheat and split.

Manufacturer Narrative

Details of the complaint on on (b)(6) 2019, (b)(6) at (b)(6) reported the transmitter (zm-530pa sn: (b)(6)) had overheated and caused batteries to split open.Investigation conclusion: the root cause of the heat damage is determined to be transmitter design did not foresee possibility of short circuit from incorrect insertion of the battery.Assessment determined that in a worst case scenario, the probability of harm is "unlikely or remote" as the maximum exterior temperature (42.6 c) is below the minimum temperature (44 c) that can cause a burn after prolonged (greater than 5 hours) skin exposure.The overall risk of this complaint is determined to be low.A new design change has been introduced to the transmitter rear case which would add an insulating sheet to prevent short circuit of the battery caused by incorrect battery insertion.

Event Description

The customer reported that they believe that their transmitter was drawing in too much power from the batteries, which was causing them to overheat and split.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 9258253
• MDR Text Key: 164614911
• Report Number: 8030229-2019-00609
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2020
• Distributor Facility Aware Date: 02/05/2020
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1