MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-521PA

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

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter was not on a patient at the time that this unit overheated.They are not sure what caused this to overheat.Nihon kohden technical support (tech support) asked them for more details and was told that the unit was about to be used and found that battery compartment area was already melted.Patient information and concomitant device information will not be available as the device was not in patient use.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 reported that the telemetry transmitter was not on a patient at the time that this unit overheated.They are not sure what caused this to overheat.Nihon kohden technical support (tech support) asked them for more details and was told that the unit was about to be used and found that battery compartment area was already melted.

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter was not on a patient at the time that this unit overheated.They are not sure what caused this to overheat.Nihon kohden technical support (tech support) asked them for more details and was told that the unit was about to be used and found that battery compartment area was already melted.Patient information and concomitant device information will not be available as the device was not in patient use.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.The following is not regarding the device information for the mdr itself, but to explain why this report was not late as the initial mdr was submitted on 03/06//21 at 11:16:58 am pst pm per webtrader sent box.We also had written to the help desk about this at emdr@fda.Hhs.Gov and cesubhelpdesk@fda.Hhs.Gov the mdr was filed on the due date of 03/06/21, but the acknowledgements did not arrive till 03/07/2021.Below are the acknowledgements from the initial submission with the time stamps that illustrate that the mdr was filed on time and not late.Messageid: <16727514.49.1615058218811@bh9c1g2>, coreid: ci1615058220003.5718201@fdsuv08638_te2, datetime receipt generated: 03-06-2021, 14:17:58."cdrh has received your submission." ack3: this submission has been sent to the production system and has been processed by the fda.Please refer to the summary section below to determine if this submission has passed or failed.Ci1615058220003.5718201@fdsuv08638_te2 8030229-20210306111339 sun mar 07 17:38:56 est 2021 0 1 form 3500a - icsr r2 passed submission summary: environment: ack3: this submission has been sent to the production system and has been processed by the fda.Please refer to the summary section below to determine if this submission has passed or failed.Submission type: form 3500a - icsr r2, core id: ci1615058220003.5718201@fdsuv08638_te2, batch id: 8030229-20210306111339, date entered: sun mar 07 17:38:56 est 2021, summary: passed: 1, failed: 0.Report list: report number: 8030229-2021-00116, passed.

Event Description

The biomedical engineer reported that the telemetry transmitter was not on a patient at the time that this unit overheated.They are not sure what caused this to overheat.Nihon kohden technical support (tech support) asked them for more details and was told that the unit was about to be used and found that battery compartment area was already melted.

Event Description

The biomedical engineer reported that the telemetry transmitter overheated, but it was not on a patient at the time.They were not sure what caused the unit to overheat.When setting the device up for patient use, they found that the battery compartment had already melted.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the telemetry transmitter overheated, but it was not on a patient at the time.They were not sure what caused the unit to overheat.When setting the device up for patient use, they found that the battery compartment had already melted.Investigation summary: the device was sent in for nk evaluation and the reported problem was duplicated.The necessary parts were replaced and the device was tested per the zm-520/521pa operator's manual.The unit completed 24 hours of testing.A previous nkc investigation identified that 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 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 tn-1231).The design change has been applied to the following serial numbers: (b)(6).The complaint device zm-531pa 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.

• Brand Name: ZM-521PA
• 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; 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: 11429546
• MDR Text Key: 249030664
• Report Number: 8030229-2021-00116
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• 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,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 03/07/2021; 04/20/2023
• Supplement Dates FDA Received: 03/14/2021; 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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