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

Model Number ZM-520PA

Device Problems Device Inoperable (1663); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is over heating and getting extremely warm.This was noticed by a nurse when checking the transmitter while it was sitting next to the patient.The device was returned to nihon kohden, evaluated, and the issue reported by the customer could not be confirmed.The device returned by the customer was tested for 3 days with fresh batteries and nihon kohden could not reproduce the issue reported by the customer.Nihon kohden provided customer with an exchanged device.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 is over heating and getting extremely warm.This was noticed by a nurse when checking the transmitter while it was sitting next to the patient.

• Brand Name: ZM-520PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5352720
• MDR Text Key: 35313934
• Report Number: 8030229-2016-00005
• 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
• Report Date: 01/07/2016,12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• 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: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2016
• Distributor Facility Aware Date: 12/08/2015
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2016
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2011
• 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