MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number ZM-541PA

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437); Battery Problem (2885)

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

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.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 the transmitter overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.

Manufacturer Narrative

The customer reported that the transmitter overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.The unit was cleaned and evaluated.The reported problem of the battery contacts are melted was duplicated.All malfunctioning parts have been replaced.The unit was tested per the operator's manual and the results were recorded on the maintenance check sheet.The unit completed one day of extended testing and operates to manufacture's specifications.Top case was damaged apparently caused by customer installed battery contact r improperly.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-541PA
• 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 mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5828409
• MDR Text Key: 51279174
• Report Number: 8030229-2016-00362
• 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: 07/27/2016,06/27/2016

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2016
• Distributor Facility Aware Date: 06/27/2016
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2016
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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