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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter does not power on.When they put in new batteries, it does not turn on, they get no audio or anything showing on the display.Later on (b)(6) 2020, it was reported that the transmitter had overheated and that the battery compartment was melted and that the batteries were hot when removed from the transmitter.The device went into signal loss and when they checked the device, this was when they discovered this issue.No patient harm reported.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.Additional model information: concomitant medical device: the following device(s) were being used in conjunction with the telemetry transmitter, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Central nurse's station: model: ni, sn: ni.

Event Description

The biomedical engineer reported that the telemetry transmitter does not power on.When they put in new batteries, it does not turn on, they get no audio or anything showing on the display.Later on (b)(6) 2020, it was reported that the transmitter had overheated and that the battery compartment was melted and that the batteries were hot when removed from the transmitter.The device went into signal loss and when they checked the device, this was when they discovered this issue.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter would not power on.They tried new batteries, which did not resolve the issue.It was later reported that the transmitter had overheated, melting the battery compartment and the batteries were hot when removed from the transmitter.No harm or injury was reported.Investigation summary: a previous investigation identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The most probable cause of the issue is improper battery insertion.It is remote or unlikely to cause patient death or life-threatening permanent impairment.This is because the maximum exterior temperature is below the minimum temperature that can cause a burn after prolonged (greater than 5 hours) skin exposure.The operator's manual provides instruction on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (ref tn-1231).The design change has been applied to the following serial numbers: zm-520pa - serial (b)(6) or later zm-521pa - serial (b)(6) or later zm-530pa - serial (b)(6) or later zm-531pa - serial (b)(6) or later a design change has been implemented to the product to prevent short circuit of the battery during battery insertion.The complaint device was manufactured prior to this change.

Event Description

The biomedical engineer reported that the telemetry transmitter does not power on.When they put in new batteries, it does not turn on, they get no audio or anything showing on the display.Later on 10/19/2020, it was reported that the transmitter had overheated and that the battery compartment was melted and that the batteries were hot when removed from the transmitter.The device went into signal loss and when they checked the device, this was when they discovered this issue.No patient harm reported.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10841725
• MDR Text Key: 242591756
• Report Number: 8030229-2020-00682
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• 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: 11/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2015
• 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
• Treatment: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION