MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter overheated.No patient harm reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter overheated.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.Attempt #1: on (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back that the information was unknown.Additional device information: concomitant medical products: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1: on (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back that the information was unknown.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter overheated.No patient harm reported.Service requested / performed: customer reported that their transmitter got hot.The complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the heating complaint on the device.Investigation conclusion: customer reported that their transmitter got hot.The complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the heating complaint on the device.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 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 instruction on how to properly insert the batteries on the device.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt #1 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back that the information was unknown.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back that the information was unknown.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional manufacturer narrative.H11 corrected data.Corrected information: report number: it has just been discovered that the initial mdr report was sent with the incorrect year of 2021.This is to notify that the correct year should be 2022.(note: the year in the actual field has not been changed.).

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter overheated.No patient harm reported.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• 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: 14794798
• MDR Text Key: 303294064
• Report Number: 8030229-2021-02931
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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: NI.; NI.