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

Model Number ZM-541PA

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 152320603
• Report Number: 8030229-2019-00314
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 10/23/2019
• Distributor Facility Aware Date: 10/14/2019
• Device Age: 98 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS.; CNS.