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

Model Number	ZM-520PA
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported signal loss on multiple channels.No consequence or impact to the patient was reported.The reported device was returned and evaluated.During evaluation, the reported complaint of signal loss" was duplicated.All malfunctioning parts were replaced.The unit was tested per the operator's manual - service manual.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.The device was returned to the customer.
Event or Problem Description
It was reported signal loss on multiple channels.No consequence or impact to the patient.
Event or Problem Description
It was reported signal loss on multiple channels.No consequence or impact to the patient.
Additional Manufacturer Narrative
H10: additional narrative: details of complaint: on (b)(6) 2018, customer stated transmitter was giving signal loss error message.Customer requested repair services.Service requested: repair.Service performed: repair.Investigation result: nka repair center replaced the following parts to resolve the issue: cd-323p center case assembly.110168 o-ring.6114918572a case sealant.Device was delivered to customer on (b)(6) 2018.Service history for this device shows no other service notifications.Service history for this customer shows three additional incidents around the same time: 48641: reported on (b)(6) 2019.Customer was complaining of noisy signal.Nka repair center evaluated the device.The reported issue could not be duplicated.48642: reported on (b)(6) 2019.Customer was complaining of noisy signal.Physically damaged parts were replaced: screen, select key, front case assembly, center case assembly.48821: reported on (b)(6) 2019.Org receiver was reported to be causing signal loss.The root cause was due to device not having power.The above history shows there were two incidents of zm transmitters suffering from signal issues due relating to damages to the center case assembly.The issue was resolved once the center case assembly was replaced.The root cause of the reported issue here was due to physical damages.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Please see attached dhr review form.Corrected information: f9.Approximate age of device: incorrectly calculated.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? additional information.Correction.Device evaluation.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• Brand Name: ZM-520PA
• 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: 8198083
• Report Number: 8030229-2018-00495
• Device Sequence Number: 295493
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019
• Report Date (Section F): 07/22/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/22/2019