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

Model Number	ZM-541PA
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer that the transmitter keeps indicating wrong readings.When the customer check the patient readings on the cns, the readings differ and the patient's vitals seem fine.No consequence or impact to the patient 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 if additional information becomes available.The following devices were being used in conjunction with the transmitter: central monitoring system (cns).
Event or Problem Description
The customer that the transmitter unit keeps indicating wrong readings.When the customer check the patient readings on the cns, the readings differ and the patient's vitals seem fine.No consequence or impact to the patient was reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019 customer stated transmitter device gives inaccurate readings, differed what was showing on the cns.Customer did not provide information regarding the cns setup, clinical settings or what parameters were being monitored.Attempts were made to follow up with customer but no responses were received.Device was not sent to nka for evaluation.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: transmitter zm-541pa s/n (b)(6) was put into service on 5/2/2013.Service history shows no similar incidents.Due to lack of information provided, the root cause could not be determined.D11.Concomitant medical products: the following devices were being used in conjunction with the transmitter: central monitoring system (cns).Customer did not provide model/serial.
Event or Problem Description
The customer that the transmitter unit keeps indicating wrong readings.When the customer check the patient readings on the cns, the readings differ and the patient's vitals seem fine.No consequence or impact to the patient was reported.

• 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: 8829370
• Report Number: 8030229-2019-00314
• Device Sequence Number: 2470551
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/23/2019
• Report Date (Section F): 10/23/2019

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2019
• Device Age: 98 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS.; CNS.
• Date Report Sent to FDA: 10/23/2019