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

Model Number	ZM-540PA
Medical Device Problem Codes	Electrostatic Discharge (2149); Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the nurse was shocked when trying to place batteries into the transmitter.The biomedical engineer then tested the device and the batteries overheated.The batteries were thrown away.There were no signs of physical damage or fluid intrusion.There was no report of patient injury and the nurse was not seriously injured.The biomedical engineer was provided with an exchanged device.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 nurse was shocked when trying to place batteries into the transmitter.The biomedical engineer then tested the device and the batteries overheated.
Additional Manufacturer Narrative
The biomedical engineer reported that the nurse was shocked when trying to place batteries in the transmitter.The biomedical engineer then tested the device and the batteries overheated.The batteries were thrown away.There were no signs of physical damage or fluid intrusion.There was no report of patient injury and the nurse was not seriously injured.The biomedical engineer was provided with an exchanged device.The investigation has determined the complaint cannot be duplicated.

• Brand Name: ZM-540PA
• 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: 6802653
• Report Number: 8030229-2017-00264
• Device Sequence Number: 11022769
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017
• Report Date (Section F): 08/17/2017

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: 07/31/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2017
• Device Age: 95 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/19/2017
• 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: 08/17/2017