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

Model Number ZM-520PA

Device Problems Overheating of Device (1437); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter got very hot and was producing smoke.The biomed was able to duplicate the problem by using one fully charged and one almost depleted battery.The biomed was provided the proper batteries to use and disposed of the ones that were causing the smoke.The device was in use on a patient, however no patient harm was reported.Nihon kohden continues to investigate the reported event.The device was sent in for an exchange.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the transmitter got very hot and was producing smoke.

Manufacturer Narrative

The customer reported that the transmitter got very hot and was producing smoke.The biomedical engineer (bme) was able to duplicate the problem by using one fully charged and one almost depleted battery.The bme was provided the proper batteries to use and disposed of the ones that were causing the smoke.The device was in use on a patient, however no patient harm was reported.The device was sent in for exchange.The unit was evaluated and 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 an nkc investigation on a similar incident, is indicative of improper battery insertion.(b)(4) will submit a supplemental report in accordance with 21 cfr part 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; gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 6046212
• MDR Text Key: 58020614
• Report Number: 8030229-2016-00523
• Device Sequence Number: 1
• Product Code: DRT
• 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: 10/20/2016,09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• 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: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2016
• Distributor Facility Aware Date: 09/20/2016
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2016
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• 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