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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

An exchange was sent to the customer.We could not duplicate the problem and put back into inventory.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of any product and this report only represents an enhancement to the reporting criteria going forward.

• Brand Name: ZM-920PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORP.; 486 nanokaichi; tomioka city, gunma ; JA
• Manufacturer Contact: 1-31-4 nishiochia, shinjuku-ku; tokyo 161-8-560 ; 7050350
• MDR Report Key: 4390924
• MDR Text Key: 19973967
• Report Number: 8030229-2014-00122
• Device Sequence Number: 1
• Product Code: DRG
• 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
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 03/30/2012
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1