MAUDE Adverse Event Report: NIHON KOHDEN CORP. ZM-920PA; TELEMETRY TRANSMITTER

Device Problems Radiofrequency Interference (RFI) (2314); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Imp ref # (b)(4).

Manufacturer Narrative

The customer used a transmitter that did not have issues on the same receivers, and it worked fine.Awaiting requested device for repair and failure investigation.

Manufacturer Narrative

The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.The main pcb was defective.Cleaned the unit and replaced the defective parts.Device was repaired and returned to the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-920PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORP.
• Manufacturer Contact: 1-31-4 nishiochia; shinjuku-ku; tokyo 161-8-560 ; 9492687708
• MDR Report Key: 4802835
• MDR Text Key: 16067748
• Report Number: 8030229-2015-00111
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• PMA/PMN Number: K945578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1