MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; RECEIVER UNIT

Device Problem Device Stops Intermittently (1599)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

The failure was duplicated and found to be related to corruption of the operating software.The software was reset to factory defaults and customer's settings restored.The issue did not recur upon testing.Returned repaired unit to the customer 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: ORG-9100A
• Type of Device: RECEIVER UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION
• Manufacturer Contact: 1-31-4 nishiochia, shinjuku-ku; tokyo 161-8-560 ; 7050350
• MDR Report Key: 4385868
• MDR Text Key: 16304697
• Report Number: 8030229-2014-00127
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 07/22/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1