MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-540PA; TRANSMITTER

Model Number	ZM-540PA
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019); Alarm Not Visible (1022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the transmitter did not v-fib alarm while the patient was being monitored on the cns.The device was in use on a patient, however no patient harm was reported.The customer sent the device in and was provided with a transmitter exchange.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.
Event or Problem Description
The biomedical engineer reported that the transmitter did not v-fib alarm while the patient was being monitored on the cns.
Additional Manufacturer Narrative
The biomedical engineer reported that the transmitter did not v-fib alarm while the patient was being monitored on the cns.The device was in use on a patient; however no patient harm was reported.The customer sent the device in for evaluation and was provided with an exchanged device.The unit was cleaned and evaluated and the reported problem was not duplicated.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.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.

• Brand Name: ZM-540PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• MDR Report Key: 6348143
• Report Number: 8030229-2017-00049
• Device Sequence Number: 34996
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017
• Report Date (Section F): 02/21/2017

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-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2017
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/21/2017