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 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter overheated and had to be removed from the patient.This happens intermittently.No patient harm was 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.Attempt #1 05/17/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 05/30/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 06/02/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device 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.Attempt #1 05/17/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 05/30/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 06/02/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station (cns) model: ni.Sn: (b)(4).Multiple patient receiver (org) model: ni.Sn: (b)(4).

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter overheated and had to be removed from the patient.This happens intermittently.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter overheated and had to be removed from the patient.This happens intermittently.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter overheated and had to be removed from the patient.This happens intermittently.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 (b)(4).The design change has been applied to the following serial numbers: (b)(6) - serial (b)(6) or later (b)(4) - serial (b)(6) or later (b)(4) - serial (b)(6) or later (b)(4) - 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.

• 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: 11963396
• MDR Text Key: 268277515
• Report Number: 8030229-2021-00326
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2014
• 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 (CNS); CENTRAL NURSE'S STATION (CNS); MULTIPLE PATIENT RECEIVER (ORG); MULTIPLE PATIENT RECEIVER (ORG)