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

Model Number	ZM-540PA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomed reported that the middle battery is shorting out and believes it is that terminal that is getting hot and causing the device to shut down.Customer was provided an exchange transmitter.No patient injury 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.
Event or Problem Description
The biomed reported that the middle battery is shorting out and believes it is that terminal that is getting hot and causing the device to shut down.Customer was provided an exchange transmitter.No patient injury reported.
Additional Manufacturer Narrative
The biomed reported that the middle battery is shorting out and believes it is that terminal that is getting hot and causing the device to shut down.Customer was provided an exchange transmitter.No patient injury reported.The device was returned from the customer with the negative and positive terminals shorted together.The short will cause the reported problem.This issue is related to how the device was handled in the field and is not a malfunction of the device.
Event or Problem Description
The biomed reported that the middle battery is shorting out and believes it is that terminal that is getting hot and causing the device to shut down.Customer was provided an exchange transmitter.No patient injury reported.
Additional Manufacturer Narrative
Details of the complaint.On (b)(6) 2019, customer at (b)(6) hospital reported the middle battery of the transmitter (zm-540pa sn: (b)(6) ) was always shorting out.She believed the middle battery terminal was getting hot and causing the device to shut down.Investigation result: per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The device was delivered to medical center hospital on 09/28/15, and the issue occurred after over 3 years at the customer facility.Review of device sap history found no additional issue reported for the unit.The image shows melting of the plastic behind the negative terminal of the middle battery compartment.The positive battery terminal next to it is incorrectly positioned, which suggests an incorrect repair was attempted.The unit has no prior nka repair history, which indicates that the repair was performed outside of nka.The zm-540pa operator's manual advises the following: (1) the instrument must receive expert, professional attention for maintenance and repairs.(2) never disassemble or repair the transmitter.If there is any problem with the transmitter, contact your nihon kohden representative.Due to the improper positioning of the battery terminal, the short circuit occurred.The root cause is determined to be incorrect repair leading to use of the transmitter outside its design specification.Investigation conclusion: due to the improper positioning of the battery terminal, the short circuit occurred.The root cause is determined to be incorrect repair leading to use of the transmitter outside its design specification.

• 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: 8380439
• Report Number: 8030229-2019-00054
• Device Sequence Number: 3013618
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/23/2020
• Report Date (Section F): 01/23/2020

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2020
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019; 01/21/2020
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/22/2019; 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/23/2020