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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

The customer sent the unit in for repair.The unit completed 2 days of extended testing and completed all steps in the maintenance check sheet, per the service manual, and operates to manufacturer's specification.The reported issue could not be duplicated.It was found that a problem with the ip address at the customer facility caused the issue.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the org was in signal loss on all channels.

Manufacturer Narrative

H10: additional narrative: customer stated org's receivers are in communication loss.Service requested: repair.Service performed: repair.Investigation result: nka repair center evaluated the device.It was noted that org device functioned as intended.However, the ip setting on this org was set to "auto-ip" instead of the required "static ip".This caused the device's ip to differ from the label.Device was returned to customer as "could not duplicate".Customer reported that the device still does not work and was not interested in troubleshooting.Upon re-evaluation, no issues were found.Device undergone two days of testing.Device performed as intended.Service history for shows one additional ticket: 47992.Ticket 47992 was created to document the second report (stated above) that device didn't work when returned to customer.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Please see attached dhr review form.Based on the above information, there is no indication that reported communication loss was caused by the org device.The root cause could not be determined.Corrected information: f9.Approximate age of device: incorrectly calcuated g4.Date received by manufacturer: should be 12/03/2018 not 12/27/2018 as listed on mdr initial report.

Event Description

The biomedical engineer (bme) reported that the org was in signal loss on all channels.

• 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: 8201276
• MDR Text Key: 131580418
• Report Number: 8030229-2018-00502
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2019
• Distributor Facility Aware Date: 07/16/2019
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1