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

Model Number ZM-520PA

Device Problems Device Emits Odor (1425); Smoking (1585); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 03/09/2017

Event Type  malfunction  

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 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.

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
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 6459175
• MDR Text Key: 71907068
• Report Number: 8030229-2017-00095
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/04/2017,03/09/2017

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Distributor Facility Aware Date: 03/09/2017
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2017
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1