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 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

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 biomedical engineer (bme) reported that the transmitter became very hot while the nurses were setting it up to be put on a patient.The nurses removed the batteries.The biomed tested it in their shop, and the transmitter did become extremely hot.They can see where the case was starting to melt, and they have indicated they are using the same (b)(6) batteries they always use.However, for some reason, this unit is overheating.This was not in patient use and no harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter became very hot while the nurses were setting it up to monitor a patient.The nurses removed the batteries.The bme tested it in the shop, duplicating the issue and found that the case was starting to melt.The customer sent the unit in for evaluation.Investigation summary: the complaint unit was returned by the customer, and it was evaluated by nihon kohden repair center (nk rc).Nk rc was able to duplicate the reported issue.A previous nkc 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 duplicated by nk rc, 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 transmitter became very hot while the nurses were setting it up to monitor a patient.The nurses removed the batteries.The bme tested it in the shop, duplicating the issue and found that the case was starting to melt.They were using duracell batteries as they had always done.This was not in patient use and no 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 ; 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: 12866367
• MDR Text Key: 283769332
• Report Number: 8030229-2021-01992
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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