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

Model Number ORG-9100A

Device Problem Loss of Power (1475)

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

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the org lost power due to a failed ups device.The bme stated that when performing a bi-monthly generator test, 3 of the 4 ups devices did not switch back to ac power once the generator test was over.After 1.5 hours the telemetry devices went into communication loss for 30-40 minutes, due to the loss of power to their 12 org devices.The bme wanted to know if he could use a different brand of ups to restore power to the orgs and was advised that he could.This resolved the issue.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the org lost power due to a failed ups device.

Manufacturer Narrative

H10: additional narrative: (b)(6) at (b)(6) hospital reported that the facility performs bi-monthly generator tests.When they do, the upss in the org closet kick on when the test starts and switch back to ac.On this occassion, 3 out of the 4 orgs did not go back to ac and after 1.5 hours all telemeters went down with communication loss.They were down 30-40 minutes until it was discovered that the upss did not switch back to ac power.There were also switches and media converters plugged into the ups.The customer's it team has all their equipment plugged into their blue outlets which are connected to the house ups service requested: customer requests to know if it is acceptable for the nk equipment to be plugged into the house ups instead.Service performed: customer was advised that he could use a different ups on nk equipment.Investigation result: the root cause was a failure of the ups.Per manufacturer's manual, the batteries are designed to last from 2-5 years but their actual life span will depend on several factors including how often power outages occur, how long power outages last, and the temperature of the environment in which the ups operates.The org listed has been in service since 2010, which is approximately 8 years at the time of reported issue.If the battery had not been replaced during that time,this would indicate that the customer was using the ups well past its expected life expectancy.In addition, the performance of bi-monthly generator tests would have a negative effect on the lifespan of the battery as well.The ups is a supporting accessory not a device.The org and telemetry devices were operating within specifications.There was no indication of improper or inadequate device design.The device was not in use with a patient and there was no reported harm.This issue is not suspected to be caused by deficient device or design.Based on the given information, this complaint record can be closed.Corrected information: g4.Date received by manufacturer: should be 05/23/2018 not 06/21/2018 as listed on mdr initial report.

Event Description

The biomedical engineer (bme) reported that the org lost power due to a failed ups device.

• Brand Name: ORG-9100A
• 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: 7626527
• MDR Text Key: 111999825
• Report Number: 8030229-2018-00220
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Distributor Facility Aware Date: 05/13/2019
• Device Age: 103 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1