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

Model Number ZM-531PA

Device Problems Overheating of Device (1437); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported that their transmitter is no longer transmitting wirelessly.The customer also reported that the unit battery overheated.They confirmed that the battery in question did cause some discomfort to the nurse, but not to the patient.They will be sending this unit in for an exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt #1: 01/28/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: 02/11/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3 02/24/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #1: 01/28/2021 emailed the customer via microsoft outlook for relevant test/labs: no reply was received.Attempt #2: 02/11/2021 emailed the customer via microsoft outlook for relevant test/labs: no reply was received.Attempt #3 02/24/2021 emailed the customer via microsoft outlook for relevant test/labs: no reply was received.Attempt #1: 01/28/2021 emailed the customer via microsoft outlook for other relevant history: no reply was received.Attempt #2: 02/11/2021 emailed the customer via microsoft outlook for other relevant history: no reply was received.Attempt #3 02/24/2021 emailed the customer via microsoft outlook for other relevant history: no reply was received.Attempt #1: 01/28/2021 emailed the customer via microsoft outlook for involved concomitant products: no reply was received.Attempt #2: 02/11/2021 emailed the customer via microsoft outlook for involved concomitant product: no reply was received.Attempt #3 02/24/2021 emailed the customer via microsoft outlook for involved concomitant product: no reply was received.

Event Description

The customer reported that their transmitter is no longer transmitting wirelessly.The customer also reported that the unit battery overheated.They confirmed that the battery in question did cause some discomfort to the nurse, but not to the patient.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter was no longer transmitting wirelessly.The customer also reported that the device's battery overheated.They reported that the battery caused some discomfort to the nurse, but not to the patient.Investigation summary: the transmitter was brought in for evaluation.During the evaluation of the reported device nihon kohden repair center (nk rc) was able to duplicate the reported issue of the device not transmitting wirelessly.The evaluation found that the unit had electronic failure.Hardware failure could come as a result of physical, heat, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The device was installed in (b)(6) 2016.The reported issues of physical damage and degraded function keys were also observed.The physical damage and hardware failure may have contributed to the heating of the device.A complaint history review of the customer's account does not reveal trends for similar complaints.Wear and tear is a likely factor in the device's failure due to its age.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: d10 attempt #1: 01/28/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: 02/11/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3 02/24/2021 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The customer reported that the transmitter was no longer transmitting wirelessly.The customer also reported that the device's battery overheated.They reported that the battery caused some discomfort to the nurse, but not to the patient.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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: 11374550
• MDR Text Key: 240424520
• Report Number: 8030229-2021-00098
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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
• Patient Outcome(s): Other