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

Model Number ORG-9110A

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the org is causing noise-artifact.No consequence or impact to the patients were reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported that the org is causing noise-artifact.No consequence or impact to the patients.

Manufacturer Narrative

Details of the complaint on 03/22/2019, nk employee brian miller reported issue with the multiple patient receiver (org-9110a sn: (b)(6)) at citizens medical center.Brian was onsite performing testing with the transmitters and issues with external noise or spo2 waveforms not showing correctly.The issue was occurring on all the transmitters on the org.Receiver cards were not troubleshot due to lack of extra receiver cards.The spo2 waveform looked good on the transmitter itself.There was no issue with ekg.Service requested troubleshooting/assistance.Service performed org was recommended to be returned to nka for evaluation.Investigation result per nkc dhr (attached), the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The device warranty began 03/15/2013, which is over 6 years prior to the reported issue.A review of device history found no previously reported issues with the unit or nka servicing performed.Qa trending was performed to review all complaints listed with product org-9110a.There were a total of 138 tickets found.A review of the tickets found 2 similarly reported issues: (1) 20117 reported 01/22/18 for org-9110a sn: (b)(6); customer reported artifact on the waveform.Troubleshooting determined the signal looked improved upon changing the receiver card.Receiver version not provided (2) 33579 reported 07/10/2018 for org-9110a sn:(b)(6); customer reported unit was getting tall spike in the ecg waveform.This is not related to the current issue.Similar tickets query using keywords "spike* receiver" found related tickets: 8155 reported 06/16/2017 for org-9110a sn: (b)(6); customer reported spikes on the spo2 waveform and disappearing values.Nka evaluation confirmed the reported issue.The receiver was rev ad.The part zr-920p was replaced with newer version af to resolve the issue.The unit was operating within specifications after repair.8156 reported 06/16/2017 for org-9110a sn: (b)(6); customer reported spikes on the spo2 waveform and disappearing values.Nka evaluation confirmed the reported issue.The receiver was rev ad.The part zr-920p was replaced with newer version af to resolve the issue.The unit was operating within specifications after repair.Similar tickets query using keywords "spo2 receiver" found related tickets: 16989 reported 12/08/2018 for org-9110a sn: (b)(6); customer reported noise caused by the receiver card zr-920p.Customer was to order new receiver card to resolve the issue.Receiver version not provided.Similar tickets query using keywords "spo2 spike*" found no related tickets.Capa 14-003 was opened 03/31/14 to address a similarly reported issue in which multiple org-9110a units were reported to have spiking on the respiration and/or spo2 waveforms with no spiking, noise, or distortion seen on the ecg waveform.Issue was reproduced at nka upon testing of unit sn: (b)(6).The org's receiver revision was af.Three orgs (sn: (b)(6)) with the reported issue were sent to nkc for evaluation.Nkc identified the cause of the issue was a defective filter in the zr-920r.This was believed to be an individual defect and isolated to the device under investigation.Nkc recommended measure was to exchange the org-9110a.7 org's were found to have been returned to nka due to spiking/excessive noise on the spo2 waveform: 300000390 10/4/2014 ssm (b)(6) health center 266 unknown 300007201 1/7/2015 va med center - pittsburgh 861 unknown 300051703 7/21/2016 decatur general hospital 283 unknown 300051706 7/21/2016 (b)(6) hospital 276 ad 300084720 5/18/2017 alliance health deaconess hospital 368 unknown 300087149 6/16/2017 (b)(6) hospital 329 ad 300087150 6/16/2017 winthrop university hospital 328 ad in each case above, the receiver cards were replaced to resolve the issue.Per (b)(4) initiated on 07/18/2019, it was found that the reception sensitivity deteriorated when the frequency of the zr-920p shifted in the (+) direction.Revision ag of the receiver card zr-920p consists of an altered filter peripheral circuit which can absorb the change of frequency characteristic.The root cause of the spo2 spiking issue is due to deterioration of the reception sensitivity of the zr-920p filter.This issue has been corrected in zr-920p revision ag.Nkc recommendation for this issue is to exchange the zr-920p.

Event Description

It was reported that the org is causing noise-artifact.No consequence or impact to the patients.

• 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: 8579913
• MDR Text Key: 144408975
• Report Number: 8030229-2019-00124
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• 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: 11/21/2019
• Distributor Facility Aware Date: 11/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1