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

Model Number ORG-9110A

Device Problems Radio Signal Problem (1511); Device Issue (2379); Wireless Communication Problem (3283)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that three departments experienced communication loss.Nihon kohden provided troubleshooting tips, such as checking the switches and the rns monitor.It was found that an org was causing the issue.The org was restarted and this resolved the issue.No harm was reported.

Event Description

The biomedical engineer reported that three departments experienced communication loss.

Event Description

The biomedical engineer reported that three departments experienced communication loss.

Manufacturer Narrative

H10: additional narrative: customer stated that they were experiencing communication loss with telemetry units in three departments: 1 specialty, 2 west, and 5 north.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: nk ts assisted customer in checking the network switches and org receivers.The issue was narrowed down to one org in segment.20 (org-9110a serial number (b)(6).The org was rebooted to resolve the communication issue.The same troubleshooting steps were taken for the other two departments.Information on the other two org receivers are not available.Service history for org-9110a serial number (b)(6)shows no other tickets have been created.Customer's service history shows that the cause communication loss related to org receiver was due to the customer's network infrastructure.Ticket 54641 shows customer was upgrading the network.There are no other org related communication loss issues after that.Corrected information: g4.Date received by manufacturer: should be (b)(6) 2018 not (b)(6)2018 as listed on mdr initial report.

• 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: 7546767
• MDR Text Key: 109361395
• Report Number: 8030229-2018-00177
• 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: 08/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Distributor Facility Aware Date: 06/19/2019
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1