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

Model Number ORG-9110A

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter.This is a use error issue as the appropriate leads were not used for arrythmia analysis and the recommendation was to use multi-read analysis or change trace 1 to ii lead and do single-read analysis.This is not a device failure.Nkc investigation: in single-lead analysis, some qrs complexes were not detected due to low amplitude, and the remaining qrs-detected beats were judged as the v-tach alarm did not occur.The average heart rate decreased slightly to about 72 bpm, but it did not alarm because bradycardia was set to 50 bpm or less.Therefore, it is determined that the v-tach alarm did not occur because trace 1 has low amplitude.Recommendation: use multi-read analysis or change trace 1 to ii lead and do single-read analysis.

Event Description

The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter.

Event Description

The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2019, an nka employee was notified via email of a v-tach issue.Patient strip was scanned and provided for review.The description of failure from the customer was that the device did not alarm v-tach.The issue was detected on a transmitter connected to the org-9110a sn: (b)(6).Service requested troubleshooting/assistance service performed additional information was requested, however jim did not have much.Customer was provided instructions for gathering event data.Irc was sent to nkc on 05/01/19.Investigation result the org was put into service on 04/27/17, which is almost 2 years prior to the reported issue.A review of device history found no previously reported complaints against this unit.Irc-nka300167093 was sent to nkc on 05/01/19 and analysis determined the following (see attached cayuga analysis.Pdf): review of cns event log confirmed the vt alarm did not occur at the time of 2 occurrences of vt.Based on the information available, a cross functional investigation has determined that the amplitude of the lead being monitored was too small to assess the rhythm as ventricular tachycardia.The central networking station/org requires a waveform amplitude to be.25 mv or larger in the lead being monitored in order to analyze.In this case, based on the information available , in order to generate v-tach alarm, the system would have needed to be in multi-lead analysis, or in single-lead analysis with lead ii as trace 1, based on the waveforms and information provided.It is essential to ensure the best monitoring leads assigned to trace 1 and/ or trace ii are of sufficient amplitude.A review of similar reported issues at this facility found: (1) 31638 reported (b)(6) 2018 in which customer reported a 12 beat run of vtach did not alarm.Investigation determined issue was caused by user error.Customer was advised to use different lead settings.(2) 44592 reported (b)(6) 2018 in which customer reported the cns missed a 15 beat vtach alarm.Investigation determined there was a spontaneous beat that was narrower than the ventricular paced beat.This caused the beat to be judged as a normal beat.Customer was advised to change their ecg to a waveform that would recognize the widening of qrs width.It appears that the device functionality and optimal settings/lead placement are not well understood.The root cause is determined to be user error/education needed.During this time, the cns was continuously monitoring heart rhythm and displaying results for the clinician/staff to observe.Based on the given information, the device was determined to be operating as intended.The unit failed to alarm due to end user choice of monitoring lead with a low amplitude.Corrected information: g4.Date received by manufacturer: should be 04/15/2019 not 05/15/2019 as listed on mdr initial report h3.Device evaluated by manufacturer? d11& c2 concomitant medical products: the org was being used in conjunction with the cns.

• 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: 8614167
• MDR Text Key: 145241962
• Report Number: 8030229-2019-00154
• 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: 07/25/2019

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: 07/25/2019
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CNS