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

Model Number	ZM-520PA
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that while preparing the transmitter for patient use, the transmitter had a burning smell and began to smoke.The transmitter had just been used on another patient without issue.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 reported that while preparing the transmitter for patient use, the transmitter had a burning smell and began to smoke.The transmitter had just been used on another patient without issue.
Additional Manufacturer Narrative
The customer reported that while preparing the transmitter for patient use, the transmitter had a burning smell and began to smoke.The transmitter had just been used on another patient without issue.The batteries required for this investigation were not returned.New batteries were inserted into the unit and heating could not be duplicated.Inspection of the negative contacts shows resin melting at the spring which per our investigation on a similar incident is indicative of improper battery insertion.Also, inspected interior components of unit and found evidence of fluid intrusion on the steel bracket and main board.No visual indication of battery leads shorting.Based on the above, while melting resin is indicative of incorrect battery intrusion, it is likely that fluid intrusion contributed to heating based on visual inspection of the interior of the device and account by the customer.A final determination cannot, however, be determined because batteries were not returned with the device.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ZM-520PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• MDR Report Key: 6459175
• Report Number: 8030229-2017-00095
• Device Sequence Number: 16295850
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/09/2017
• Report Date (Section F): 04/04/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/09/2017
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/10/2017
• 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: 04/04/2017