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

Model Number	ZM-541PA
Medical Device Problem Codes	Overheating of Device (1437); Human Factors Issue (2948); Temperature Problem (3022); Misassembly by Users (3133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the transmitter overheated.The device was sent in for evaluation and they were provided with an exchange.The batteries required for this investigation were not returned.The battery cover was also missing.When new batteries were inserted into the unit, heating could not be duplicated.Inspection of the spring contacts shows one badly bent spring and the inside shield showed signs of fluid intrusion.Both of these observations could contribute to the overheating observed (i.E.Fluid with improper battery insertion).
Event or Problem Description
The customer reported that the transmitter overheated.
Additional Manufacturer Narrative
Details of the complaint: on 02/12/18, customer at community health network reported the transmitter (zm-541pa sn: (b)(6) was getting hot.Service requested/performed exchange.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 warranty began on 04/23/15, and the issue occurred after almost 3 years at the customer facility.Review of device c4c history found no additional issue reported for the unit.Evaluation of the unit at nka was unable to reproduce the heating.The spring contacts were found to have one badly bent spring, and the inside shield showed signs of fluid intrusion.Zm-540pa operator's manual advises the following: this transmitter is not waterproof.If detergent or liquid spills into the transmitter, stop using it and contact your nihon kohden representative.If a wet transmitter is used, the patient or operator may receive an electrical shock or injury.The root cause is determined to be damage to the unit due to fluid intrusion.Investigation conclusion: the root cause is determined to be damage to the unit due to fluid intrusion.
Event or Problem Description
The customer reported that the transmitter overheated.

• 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: 7335990
• Report Number: 8030229-2018-00065
• Device Sequence Number: 781
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• 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): 01/22/2020
• Report Date (Section F): 01/22/2020

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-541PA
• Device Catalogue Number: ZM-541PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2020
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 01/22/2020
• 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: 01/22/2020