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

Model Number ORG-9110A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the org was getting tall spikes in the waveform while testing on a simulator with pacing detection enabled.When pacing detection was disabled the waveforms looked clean with no spikes.They tried to perform a learn ecg and ensured the transmitter was set up correctly with 6 leads and aha, but the issue persisted.They will call back when they decide on an exchange or repair.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported that the org was getting tall spikes in the waveform while testing on a simulator with pacing detection enabled.When pacing detection was disabled the waveforms looked clean with no spikes.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018, customer reported device was getting tall spikes in the waveform while testing on a simulator with pacing detection on.When pacing detection is turned off the waveforms looks clean with no spikes.Nk ts tried to do a learn ecg and made sure the transmitter was set up correctly with 6 leads and aha but issue still persist.Customer reported four different transmitter devices having the same issue as described, thus it was concluded that the issue was not on the transmitters but rather on the org receiver, org-9110a s/n: (b)(6).Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: org receiver was put into service on 12/07/2012.Warranty expired 12/07/2017.Device service history shows two additional tickets were created but were not related to this issue.During another troubleshooting session, nk ts noted the sensitivity was set to high (4), which was causing the pacing spikes to be off the strip.Org-9100a operator's manual, revision q, states the following regarding excessive sensitivity: the equipment and/or system is designed to measure bioelectrical signals with a specified sensitivity.If the equipment and/or system is used with excessive sensitivity, artifact may appear by electromagnetic interference and this may cause mis-diagnosis.When the unexpected artifact appears, inspect the surrounding electromagnetic conditions and remove this artifact source.Cns-6201 operator's manual, revision a, warns user to turn the pacing pulse detection to on when monitoring a pacemaker patient.Otherwise the pacemaker pulse is not rejected.However, even when the pacing pulse detection is set to on, the pacemaker pulse might not be rejected.When the pacemaker pulse is not rejected, the pacemaker pulse is detected as qrs and false heart rate may be indicated or critical arrhythmia such as asystole may be overlooked.Keep pacemaker patients under close observation.In the attached printout provide by customer, the pacing detection on (2nd page) shows similar behavior as "pacing mark on" described on cns-6201, operator's manual, revision a, section 13.14 page 343.Additionally, cns operator's manual also stated to adjust qrs sensitivity if the waveform was too small or too large.Based on the information presented, no device malfunction was observed.The root cause of the customer's concern was due to not understanding device functionality.Investigation conclusion: based on the information presented, no device malfunction was observed.The root cause of the customer's concern was due to not understanding device functionality.Additional information: b4.Date of this report.F6.Date user facility/ importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer reported that the org was getting tall spikes in the waveform while testing on a simulator with pacing detection enabled.When pacing detection was disabled the waveforms looked clean with no spikes.

• 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: 7764814
• MDR Text Key: 116715722
• Report Number: 8030229-2018-00299
• 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: 01/10/2020

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: 01/10/2020
• Distributor Facility Aware Date: 01/07/2020
• Device Age: 71 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1