MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the transmitter will not transmit signal causing interruption to patient monitoring, but not for very long.No consequence or impact to the patient was reported.The reported device was returned to nihon kohden; however, device evaluation anticipated, but not yet begun.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported that the transmitter will not transmit signal causing interruption to patient monitoring, but not for very long.No consequence or impact to the patient.
Event or Problem Description
It was reported that the transmitter will not transmit signal causing interruption to patient monitoring at the central nursing system (cns), but not for very long.No consequence or impact to the patient.
Additional Manufacturer Narrative
Details of complaint: on 5/1/2019 customer reported that telemetry transmitter zm-541pa (b)(6) will not transmit data to cns.The serial number of the cns was not known.The settings on the associated cns are not known.Transmitter device was sent to nka for evaluation and exchange.Nka repair center evaluated the device.The reported issue could not be duplicated.There were no issues noted.Service requested: exchange.Service performed: exchange.Investigation result: because no issues were observed with the zm-541pa (b)(6) , it is concluded the cause of the reported issue where data was not being transmitted to the cns monitor was not due to the transmitter device.Due to limited information provided, the root cause of the reported incident is unknown.Service history for this user facility shows one subsequently related zm-541pa issue: ticket 70647 - created on 10/18/2019.Customer reported issues with device was not showing ecg rhythm for leads other than lead ii.Customer was using no nk approved lead sets.Investigation conclusion: because no issues were observed with the zm-541pa (b)(6) , it is concluded the cause of the reported issue where data was not being transmitted to the cns monitor was not due to the transmitter device.Due to limited information provided, the root cause of the reported incident is unknown.Corrected information: d11 & c2: suspect medical device: changed from "not applicable" to "cns-6201".F9: approximate age of the device changed 39 months to the correct 38 months.

• Brand Name: ZM-541PA
• 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: 8656309
• Report Number: 8030229-2019-00178
• Device Sequence Number: 19404778
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• 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): 01/29/2020
• Report Date (Section F): 01/29/2020

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2020
• Device Age: 56 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CNS-6201
• Date Report Sent to FDA: 01/29/2020