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

Model Number ZM-531PA

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter overheated and the unit was extremely hot and that the telemetry tech told him that they had tried to cool the device down by taking out the battery to power it down.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.Concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer (bme) reported that the transmitter overheated and the unit was extremely hot and that the telemetry tech told him that they had tried to cool the device down by taking out the battery to power it down.No patient harm reported.

Event Description

The biomedical engineer (bme) reported that the transmitter overheated and the unit was extremely hot.They had tried to cool the device down by removing the battery to power it down.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter overheated, and the unit was extremely hot.They had tried to cool the device down by removing the battery to power it down.No patient harm was reported.Service requested / performed: evaluation: the evaluation revealed that a plastic piece where the contact spring is located was deformed from overheating and the unit would not power on.The unit was scrapped.Investigation summary: the overheating of the battery compartment could be caused due to a number of reasons, such as: the battery is inserted in a wrong polarity causing over current battery is inserted forcibly, causing fire due to short-circuit of +/- terminals short-circuit between the +/- battery terminals user does not handle nimh secondary battery and a battery charger properly, causing a short-circuit of the +/- terminals investigation determined that the reported issue could have been caused due to incorrect usage and maintenance of the nk device.Additional information: b4: date of this report.D8: was this device serviced by a third party? 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.

• 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: 10440463
• MDR Text Key: 204190147
• Report Number: 8030229-2020-00471
• 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: 08/22/2020,09/09/2022

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2020
• Distributor Facility Aware Date: 07/27/2020
• Device Age: 57 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/22/2020
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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.