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

Model Number ORG-9100A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org was causing signal loss and a lot of artifact on two transmitters.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 customer reported that the org was causing signal loss and a lot of artifact on two transmitters.

Event Description

The customer reported that the org was causing signal loss and a lot of artifact on two transmitters.

Manufacturer Narrative

Complaint details: the customer reported on 04/03/2019 that they were getting constant signal loss and a lot of artifact which is occurring on 2 specific transmitters on the org.Service requested: the customer sent in the device for repair/evaluation service provided: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The reported problem of (org-9100a, sn-(b)(6), sw version 04-20 receivers #5 and #6 was constantly having "signal loss") was not duplicated.The extensive test was performed but no problem found.The unit was tested per the operator's/service manual and the results were recorded on the attached maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.The unit was evaluated again, the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The reported problem of "the org-9100a sn-(b)(6) has transmitters constantly "signal loss" was duplicated.Repair center setup the org-9100a sn-(b)(6) and connected with the cns.After testing and monitoring for few days, rc found the transmitter #2 was having an issue with bad signal and constantly having spike.Rc replaced the following part and issue is resolved.Zr-920p receiver the unit was tested per the operator's/service manual and the results were recorded on the attached maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation result: the org-9100a; sn:(b)(6) was placed into service on 12/30/12, which is over 6 years at the time of the reported issue.A review of device history found no previously reported issue with the unit or nka servicing.A review of complaints registered by the facility found the following ticket related to signal loss issue with the org: 55527 reported on 04/03/2019- org-9100a; sn:(b)(6) ; intermittent signal loss/artifact similar complaints using "org09100a signal loss" gave the following result: 22675- intermittent signal loss; issue could not be duplicated 44712- intermittent signal loss; root cause: issue could not be duplicated 23031- comm loss/signal loss; root cause: user education 36831- signal loss; root cause: unknown 31671- signal loss; root cause: unknown 33551- signal loss; root cause: unknown 33662- intermittent signal loss; root cause: pending investigation 48821- signal loss; root cause: user error 52970- signal loss; pending investigation based on the device service history, complaints registered at customer's site, and similar search query, no adverse trend is suspected with this device.The issue was resolved by replacing the malfunction part (zr-920p receiver).The root cause of the issue was unable to be determined.The repaired unit was retuned to customer on 07/12/2019 and no further issue was reported with the unit.Review of the device history record (dhr) shows that the unit has no history of capa, ncmr, refurbishing, or other suspected defects corrected information: d10.Device available for evaluation? f9.Approximate age of device: incorrectly calculated.D11& c2 concomitant medical products: the org was monitoring two transmitters.No model/serial was provided.

• 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: 8566905
• MDR Text Key: 143620116
• Report Number: 8030229-2019-00131
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2019
• Distributor Facility Aware Date: 10/23/2019
• Device Age: 81 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1