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

Model Number ORG-9100A

Device Problem Device Stops Intermittently (1599)

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

Event Date 07/15/2013

Event Type  malfunction  

Event Description

The customer stated that they tried to select or use any feature for a specific telemetry pt and get a central monitoring system (cns) application error message.When the pt tile/receiver is selected, the cns software restarts and the error message is displayed.Mfr ref #8030229-2014-00127.

Manufacturer Narrative

The failure was duplicated and found to be related to corruption of the operating software.The 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: 4385991
• MDR Text Key: 5262333
• Report Number: 2080783-2014-00127
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2013

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2013
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2013
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1