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.

Event Description

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

Manufacturer Narrative

Details of complaint: details of complaint: on 06/20/18, (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 occasion, 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 then 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.On 1/24/2020, customer responded to nka's inquiry into the incident with the following: "this ticket remains open in error.I have answered this at least twice in the past 18 months.The age of the ups (3 each) was 8 years.The manufacturer is powervar; model/serial numbers are (b)(6).These were all on a 2 year pm/battery replacement cycle.(it is possible that i may be in error for one of the serial numbers).All 3 devices were plugged into emergency power (red) outlets and were used for providing power to components in the 6th floor org closet.From what i can recall we had the perfect storm: the main power feed into the hospital failed; also the switch-gear for the secondary main feed failed; also the emergency generator for this portion of the building failed.I'm sure the ups units operated properly, because about an hour after the main power outage i received a call for "signal loss" and "communication loss".I believe the ups units operated until their batteries were depleted.Once power was restored, all nk monitoring communication was restored and all systems operated normally.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 results: based on customer's account, the ups battery was operating as intended by evidence that the clinician did not report "signal loss" issue until an hour into the power outage.[risk assessment] the probability of this issue re-occurring is derived from c4c data.Data was pulled on (b)(6) 2020.Out of 33046 records, the ticket title is filtered for "ups" keyword.The service category is filtered to include only "pm" related incidents.Pm is referring to patient monitoring devices.File status is filtered to show only "mdr" or "qa closed - mdr" incidents.The model is filtered to show only "org-9100a" incidents.The final result shows 14 incidents where ups caused org issues.Total number of units sold is available in sap.(b)(4).Risks: the risks of org not switching back to ac power during the bi-monthly generator tests as a result of ups failure is that there would be a loss of communication between telemetry devices and the central nursing station (cns).During such communication, a corresponding message is displayed on the cns to alert clinicians of the issue.The telemetry transmitter device also displays compressed waveform and numeric data of the latest 10 minutes.If there are no alternate means of monitoring, there would be a possible loss of patient monitoring.The risk is considered "moderate" as defined under sop06-075, quality complaint investigations.Therefore, the overall risk of this event, taking into consideration of severity and probability, is medium.Zm-520 series' intended use: to transmit ecg and respiration from a patient to a nihon kohden monitor for continuous monitoring.The lcd also displays ecg, numeric values of monitoring parameters, messages and battery condition.Device also display compressed waveform and numeric data of the latest 10 minutes.Zm-530 series intended use: to transmit ecg, respiration and pulse waveforms and spo2 from a patient to a nihon kohden monitor for continuous monitoring.The front lcd displays ecg (or pulse wave), numeric values of monitoring parameters, messages and battery condition.Device also displays compressed waveform and numeric data of the latest 10 minutes.Zm-540 series' intended use: to transmit ecg, respiration and pulse waveforms, spo2 and nibp data from a patient to a nihon kohden monitor for continuous monitoring.The front lcd displays ecg (or pulse wave), numeric values of monitoring parameters, nibp measuring mode and interval, messages and battery condition.Device also displays compressed waveform and numeric data of the latest 10 minutes.Based on the reported account, the root cause of the signal loss issue was due to power outage lasting longer than ups battery's capacity, eventually depleted the ups batteries.Keyword search for "ups" in the service history for this facility shows there has been no other reported ups issues since 6/20/2018.The issue has not re-occurred.Investigation conclusion: based on the reported account, the root cause of the signal loss issue was due to power outage lasting longer than ups battery's capacity, eventually depleted the ups batteries.Keyword search for "ups" in the service history for this facility shows there has been no other reported ups issues since 6/20/2018.The issue has not re-occurred.

• 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: 7626568
• MDR Text Key: 112001909
• Report Number: 8030229-2018-00230
• 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: 01/29/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2020
• Distributor Facility Aware Date: 01/29/2020
• Device Age: 98 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1