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.

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.Additional information: b4 date of this report.F6 date uf/importer became aware of event.F7 type of report.F8 date of this report.F11 report sent to fda.F13 report sent to manufacturer?.H10 additional manufacturer narrative.The following is not regarding the 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 11:43:22 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: <11412075.52.1615059802654@bh9c1g2> coreid: ci1615059803756.3083434@fdsuv08651_te1 datetime receipt generated: 03-06-2021, 14:44:02 "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.Ci1615059803756.3083434@fdsuv08651_te1 -20210306114137 sun mar 07 17:40:16 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: ci1615059803756.3083434@fdsuv08651_te1 batch id: -20210306114137 date entered: sun mar 07 17:40:16 est 2021 summary: passed: 1, failed: 0 report list: report number: , 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.

• 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
• MDR Report Key: 11429557
• MDR Text Key: 280454075
• Report Number: 2080783-2021-00116
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/14/2021

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2021
• Distributor Facility Aware Date: 03/07/2021
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1