MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problem Radiofrequency Interference (RFI) (2314)

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

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that his operational receiver group (org) is giving signal loss on multiple channels.Customer sent the unit in for evaluation and repair.The unit was cleaned and evaluated.The reported problem of "the device gives signal loss" could not be duplicated through testing, troubleshooting, and extended operation of the device.

Event Description

The customer reported that his operational receiver group (org) is giving signal loss on multiple channels.

Manufacturer Narrative

Details of complaint on (b)(6) 2017 customer reported that org receiver was experiencing signal loss on channels e138, e146, e150.Customer stated they tested the org using a different antenna.Service requested: repair.Service performed: repair.Investigation result: device was put into service on 4/24/2013.Service history shows this is an isolated incident.Nka repair center evaluated the device.The reported signal loss issue could not be duplicated.The receiver relayed data to the monitoring cns as intended.Separately, firmware on the receiver cards (zr-920p) were updated to improve spo2 signal.This was not related to the signal loss under channels e138, e146 and e150.Since the issue could not be duplicated at nka, and information regarding the environment in which device operated in is not available, the root cause could not be determined.Correction: f9.Approximate age of device: incorrectly calcuated.

Event Description

The customer reported that his operational receiver group (org) is giving signal loss on multiple channels.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7180763
• MDR Text Key: 97072173
• Report Number: 8030229-2018-00007
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2019
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 59 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.