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

Model Number	ZM-541PA
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the transmitter's battery cover was melted and clinicians noticed a burning smell.Upon visual inspection, the biomedical engineer noticed that the battery contacts were also melted.There was no other physical damage or fluid intrusion reported.The device was in use on a patient, however no patient harm was reported.They sent the device in and it is currently awaiting evaluation.The customer was provided with an exchanged transmitter.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's battery cover was melted and clinicians noticed a burning smell.Upon visual inspection, the biomedical engineer noticed that the battery contacts were also melted.
Additional Manufacturer Narrative
Corrected data : device evaluated by manufacturer.Additional information: follow up, additional information/correction, event problem and evaluation codes.The biomedical engineer (bme) reported that the transmitter's battery cover was melted and clinicians notices a burning smell.Upon visual inspection, the bme noticed that the battery contacts were also melted.There was no other physical damage or fluid intrusion reported.The device was in use on a patient, however no patient harm was reported.They set the device in to nihon kohden for evaluation.The customer was provided with an exchanged transmitter.The cause of the transmitter overheating was due to incorrect battery installation.

• 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: 6860464
• Report Number: 8030229-2017-00302
• Device Sequence Number: 801025
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/12/2017
• Report Date (Section F): 09/12/2017

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2017
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 11/03/2017
• 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: 09/12/2017