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

Model Number	ZM-541PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the telemetry transmitter was intermittently not reading respiration and does not always read the correct values.The simulator is set for 30, and it would read 0 sometimes and varying numbers at other times.This was found at set-up and was not being used with the central nurses station which is typically a concomitant medical device.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 part 803.56 when additional information becomes available.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter was intermittently not reading respiration and does not always read the correct values.The simulator is set for 30, and it would read 0 sometimes and varying numbers at other times.This was found at set-up and was not being used with the central nurses station which is typically a concomitant medical device.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was intermittently not reading respiration and did not always read the correct values.The simulator was set for 30, and it would read 0 sometimes and varying values at other times.No patient harm or injury was reported.Investigation summary: the device was sent in for an exchange, but no evaluation was performed.With the information available, a root cause cannot be determined.Possible causes for the reported issue are incorrect settings, poor lead connections, lead wires coming off, lead misplacement, lead damage, or user error.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter was intermittently not reading respiration and did not always read the correct values.No patient harm was reported.

• Brand Name: ZM-541PA
• 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: 10116978
• Report Number: 8030229-2020-00301
• Device Sequence Number: 11583831
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/03/2023
• Report Date (Section F): 06/03/2020

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: 06/02/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2020
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2015
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/03/2020