MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number	ZM-520PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports that the transmitter batteries will get very hot when put in the device and it will not turn on.No patient harm 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 when additional information becomes available.
Event or Problem Description
The customer reports that the transmitter batteries will get very hot when put in the device and it will not turn on.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019, the customer at medical center hospital reported that the transmitter (zm-520pa sn: (b)(6) appeared to be shorting out batteries.The batteries were reported to get very hot and the device would not power on.The customer reported the unit was repaired in the hospital.Service requested / performed: troubleshooting.Investigation summary: the unit was not returned and no nka evaluation was performed.The unit was reported to have been repaired by the bme at the facility.Additional information is not readily available as the bme was no longer with the facility.From the information available, the root cause is not known.Nkc investigation performed under irc-nka300097945 concluded that incorrect insertion of the battery may cause the battery terminal spring to break the coating of the battery, leading to a short circuit.Nkc conducted a test study to monitor temperature of the transmitter upon incorrect insertion of the battery.A design change has been introduced to the product to prevent short circuit of the battery.The overall risk, as determined from the product of probability (rare) and severity (minor), is determined to be low.
Event or Problem Description
The customer reports that the transmitter batteries will get very hot when put in the device and it will not turn on.No patient harm was reported.

• Brand Name: ZM-520PA
• 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: 9307254
• Report Number: 8030229-2019-00640
• Device Sequence Number: 19423900
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• 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
• Serviced by Third Party (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): 11/12/2020
• Report Date (Section F): 11/11/2019

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/17/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 11/12/2020
• 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: 11/11/2019