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

Model Number	ZM-521PA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter started making noise and then became extremely hot.It also gave a signal loss error message.The device will be exchanged to resolve the issue.No patient harm was 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.Additional device information: concomitant medical devices: the following devices were used in conjunction with the transmitter in this report.Central nurse's stations (cns), model #: ni, sn #: ni, approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.), device manufacturer date: ni, unique identifier (udi) #: ni.Org, model #: ni, sn #: ni, approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.), device manufacturer date: ni, unique identifier (udi) #: ni.
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter started making noise and then became extremely hot and indicated signal loss on the screen.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019 customer stated that transmitter device (zm-521pa s/n (b)(6)) started making noise and then became extremely hot and indicated sign loss on the screen.Device was sent to nka for evaluation and repair.Nka repair center evaluated the device.The reported problem could not be duplicated.Battery contacts were found to be dirty and/or rusted.Please see attached pictures.Repair center also noted residue found on the rear case and center case assembly.Front case was found to have small cosmetic scratches.All cases were replaced.Service requested: evaluation and repair.Service performed: nka repair center evaluated the device.The reported problem could not be duplicated.Battery contacts were found to be dirty and/or rusted.Repair center also noted residue found on the rear case and center case assembly.Front case was found to have small cosmetic scratches.All cases were replaced.Investigation results: it is unknown how the batteries were installed when customer reported the device making noise, heating up and indicating sign loss.Due to no issues with performance were observed, the cause of the reported issue could not be determined.The cases were replaced as a result of residue and scratches.For investigation regarding overheating transmitter, please see investigation under ticket 66324 for more information.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.The following fields are not applicable (na) to the mdr report: additional device information: d11 & c2 concomitant medical devices: the following devices were used in conjunction with the transmitter in this report.Central nurse's stations (cns): model #: ni.Sn #: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni.Unique identifier (udi) #: ni.Org: model #: ni.Sn #: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni.Unique identifier (udi) #: ni.
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter started making noise and then became extremely hot and indicated signal loss on the screen.No patient harm reported.

• Brand Name: ZM-521PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9210988
• Report Number: 8030229-2019-00582
• Device Sequence Number: 3146612
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020
• Report Date (Section F): 02/06/2020

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
• Operator of Device: 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
• Distributor Facility Aware Date: 02/05/2020
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/06/2020