MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number	ZM-521PA
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the transmitter overheated causing the battery contacts to melt.The failed device will be sent in for an exchange.No patient harm or injury was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the transmitter overheated causing the battery contacts to melt.
Event or Problem Description
The customer reported that the transmitter overheated causing the battery contacts to melt.
Additional Manufacturer Narrative
Details of the complaint: on 11/22/19, customer at (b)(6) hospital reported battery heat damage to the transmitter (zm-521pa (b)(6) ).The battery contacts were melted as well as the plastic around them.Investigation conclusion: the root cause of the heat damage is determined to be transmitter design did not foresee possibility of short circuit from incorrect insertion of the battery.Assessment determined that in a worst case scenario, the probability of harm is "unlikely or remote" as the maximum exterior temperature (42.6 c) is below the minimum temperature (44 c) that can cause a burn after prolonged (greater than 5 hours) skin exposure.A new design change has been introduced to the transmitter rear case which would add an insulating sheet to prevent short circuit of the battery caused by incorrect battery insertion.

• Brand Name: ZM-521PA
• 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: 9485179
• Report Number: 8030229-2019-00732
• Device Sequence Number: 2777233
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020
• Report Date (Section F): 02/05/2020

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-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/04/2020
• Device Age: 48 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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: 02/05/2020