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 05/13/2021

Event Type  malfunction  

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

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.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was intermittently overheating and had to be removed from the patient.No harm was reported.Investigation summary: a previous nkc investigation identified that the incorrect insertion of the batteries may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the battery and device.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.Based on the available information, a definitive root cause could not be identified.However, as the issue occurred when used by the customer and was not duplicated by nk, a possible cause of the issue is improper battery insertion.The operator's manual provides instructions 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)(6) - serial (b)(6) or later (b)(6) - serial (b)(6) or later (b)(6)- serial (b)(6) or later.The complaint device (b)(6)- sn (b)(6) was made prior to this change.A design change has been implemented to the product to prevent short circuit of the battery during battery insertion.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was intermittently overheating and had to be removed from the patient.No patient harm was 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11963288
• MDR Text Key: 281027226
• Report Number: 8030229-2021-00325
• 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: 04/24/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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)