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

Model Number ORG-9100A

Device Problems Alarm Not Visible (1022); No Display/Image (1183); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)

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

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the device was having an issue with not showing extended alarms.In an effort to correct the issue the biomedical engineer attempted to reboot the device and the device came back on with a red error light and all patients went into communication loss.Patients were moved to another device.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported that the device was having an issue with not showing extended alarms.In an effort to correct the issue the biomedical engineer attempted to reboot the device and the device came back on with a red error light and all patients went into communication loss.Patients were moved to another device.

Manufacturer Narrative

The customer reported that the device was having an issue with not showing extended alarms.In an effort to correct the issue the biomedical engineer attempted to reboot the device and the device came back on with a red error light and all patients went into communication loss.Patients were moved to another device.The unit was evaluated and the error light was confirmed during 2 weeks of extended testing.The main pcb was replaced to resolve the issue.All steps in the maintenance check sheet of service manual were completed and the unit performed one more day of extended testing with the cns.The unit was configured but the channels will need to be input by the customer.The device has been repaired and returned to the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• 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, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5728279
• MDR Text Key: 48333619
• Report Number: 8030229-2016-00261
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/15/2016,05/16/2016

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-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2016
• Distributor Facility Aware Date: 05/16/2016
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2016
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1