MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number	ZM-520PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the batteries were hot in the telemetry transmitter.They replaced the batteries and the issue persists and would like the unit repaired.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 device: the following devices were being used in conjunction with the telemetry transmitter.Central nurse's station: model: cns-6201a, sn: (b)(4).
Event or Problem Description
The biomedical engineer reported that the batteries were hot in the telemetry transmitter.They replaced the batteries and the issue persists and would like the unit repaired.No patient harm was reported.
Event or Problem Description
The biomedical engineer reported that the batteries were hot in the telemetry transmitter.They replaced the batteries, but the issue persisted.They requested that the unit be repaired.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the batteries were hot in the telemetry transmitter.They replaced the batteries, but the issue persisted.They requested that the unit be repaired.No patient harm was reported.Service requested / performed: evaluation / repair: on 05/05/2020, the unit was cleaned and decontaminated by nihon kohden america repair center (nka rc).On rc evaluation, the reported problem could not be duplicated.Physical damage to the front case (hairline crack) was noticed, the battery contact on the rear case was corroded with residue found on the center case.On 05/06/2020, the following malfunctioning parts were recognized and replaced which resolved the issue: # 6142901448b front case # cd-323p center case #6142902693 rear with battery cover # 6114918572a case sealant # 110168 o-ring # 6123906559 main panel.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operated to the manufacturer's specifications.The repaired unit was shipped back to the customer on 09/23/2020.No issues have been reported since.Investigation summary: the nkc investigation performed under (b)(4) (a3-181170_final-eg) concluded that incorrect insertion of the battery may cause the battery terminal spring to break the coating of the battery, leading to a short circuit.The overall risk of this event is medium.The reported issue does not require further investigation through capa process since the issue could not be duplicated on nka rc evaluation.Hha considered the probability of harm as "unlikely or remote" in such reported cases.Also, a new design change was introduced to the transmitter's rear case which would add an insulating sheet to prevent short circuit of the battery caused by incorrect battery insertion.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the transmitter: central nurse's station (cns): model #: cns-6201a, serial #: (b)(6).

• Brand Name: ZM-520PA
• Common Device Name: 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: 10075969
• Report Number: 8030229-2020-00278
• Device Sequence Number: 2835758
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021
• Report Date (Section F): 05/20/2020

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2020
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS-6201A SN (B)(6) ; CNS-6201A SN (B)(6)
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2020