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

Model Number	ZM-541PA
Medical Device Problem Codes	Overheating of Device (1437); Device Issue (2379); Misassembly by Users (3133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the transmitter's battery contacts had melted.The device was sent in for qa evaluation.The batteries required for this investigation were not returned.However, an inspection of the battery contacts showed that the contacts were incorrectly positioned, creating a situation that could result in shorting and thus overheating.No patient harm was reported.They were provided with an exchanged transmitter.
Event or Problem Description
The customer reported that the transmitter's battery contacts had melted.
Additional Manufacturer Narrative
H10: additional narrative: on (b)(6) 2018, (b)(6) at (b)(6) reported the transmitter (zm-541pa sn:(b)(6)) had melted plastic near the battery contacts.The nurse informed him that she smelled something burning and took the transmitter off the patient and saw it was melted near the contacts.The patient and nurse were not harmed.Batteries were thrown away.Service requested: exchange service performed: exchange investigation result: the device has been in service since 2017, which is almost 1 year at the time of reported issue.A review of the device history found no previously reported issues with the unit.A review of customer's complaints found no similarly reported issues with a transmitter overheating.Qa evaluation; the batteries required for this investigation were not returned.However, an inspection of the battery contacts shows that the contacts were incorrectly positioned creating a situation that could result in shorting and thus overheating.The root cause is determined to be user error in incorrect repair/positioning of the battery contact.The device was in use with a patient and there was no reported harm.There is no indication of improper or inadequate device design.Based on the given information, this complaint record will be closed.Correction: b1.Adverse event or product problem: adverse event selected incorrectly.Malfunction should be the only selection g4.Date received by manufacturer: should be 02/20/2018 not 03/22/2018 as listed on mdr initial report.
Event or Problem Description
The customer reported that the transmitter's battery contacts had melted.

• 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: 7364159
• Report Number: 8030229-2018-00079
• Device Sequence Number: 1426780
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/26/2019
• Report Date (Section F): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/28/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/09/2019
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 08/26/2019
• 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: 08/26/2019