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

Model Number	ZM-541PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2016
Type of Reportable Event	Other
Additional Manufacturer Narrative
The customer reported that the transmitter overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.No patient harm was reported.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that the transmitter overheated and the battery contacts melted.There was no other physical damage and no fluid intrusion.

• Brand Name: ZM-541PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• MDR Report Key: 5653885
• Report Number: 2032233-2016-00362
• Device Sequence Number: 17001739
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2016
• Report Date (Section F): 06/27/2016

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: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2016
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 05/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/27/2016