MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Thermal Decomposition of Device (1071); Temperature Problem (3022)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter got hot while in patient use.No patient harm was reported.The transmitter was removed from service and patient was placed on a different transmitter.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 got hot while in patient use.No patient harm was reported.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the transmitter got hot while in patient use.The device was in use on a patient, however no patient harm was reported.The customer was provided with an exchanged transmitter and sent the failed device to nihon kohden for evaluation.The batteries required for the investigation were not returned.New batteries were inserted into the unit and the issue of overheating could not be duplicated.Inspection of the negative contacts showed melted resin at the spring which, per an nkc investigation on a similar incident, is indicative of improper battery insertion.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ZM-521PA
• 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: 6459178
• MDR Text Key: 71914499
• Report Number: 8030229-2017-00096
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• 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: 04/04/2017,03/13/2017

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• 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: 03/13/2017
• Device Age: 15 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: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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