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

Model Number ORG-9100A

Device Problems Communication or Transmission Problem (2896); Device Operational Issue (2914)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's it personnel reported that the org manifested problems resulting in communication loss on all channels.Nihon kohden technical support provided troubleshooting support and advised the customer to re-establish communication with the transmitters on the cns.One of the devices had a "communication error" so he was advised to power cycle the org.All of the channels then came up showing "communication loss." the customer was provided with a loaner and sent the org in to nihon kohden for repair.The device has been received and will undergo evaluation.No patient harm was reported.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's it personnel reported that the org manifested problems resulting in communication loss on all channels.

Manufacturer Narrative

Corrected data device evaluated by manufacturer.Event problem and evaluation codes.Additional manufacturer narrative.Additional information: follow up.Additional information/correction.Field required for submission.Additional manufacturer narrative: the customer's it personnel reported that the org manifested problems resulting in communication loss on all channels.Nihon kohden technical support provided troubleshooting support and advised the customer to re-establish communication with the transmitters on the cns.One of the devices had a "communication error" so he was advised to power cycle the org.All of the channels then came up showing "communication loss".The customer was provided with a loaner and sent the org in to nihon kohden for repair.The unit was cleaned and evaluated.The reported problem of "comm loss" could not be duplicated through testing, trouble shooting and extended operation of the device.Review of the device history indicates no previous cnd status.The unit was tested per operator's/service manual and operates to manufacturer's specifications.The customer has requested that the unit be sent back to the facility since the issue could not be duplicated.

Event Description

The customer's it personnel reported that the org manifested problems resulting in communication loss on all channels.

Manufacturer Narrative

Details of complaint: on 3/13/2018 customer stated this org receiver was powered off and was showing communication loss on the cns.When org was powered back on, the communication loss was not resolved.Service requested: repair.Service performed: evaluation.Investigation result: nka repair center evaluated the org.The reported communication loss associated with this device could not be duplicated.Device was returned customer.Org receiver was put into service on 3/22/2009.Service history shows no other service incidents.The cause of org powered off was unknown.The communication loss issue could not be duplicated.The root cause of the communication loss issue at user facility could not be determined.Date of this report.Date user facility/importer became aware of the event.Type of report.Date report sent to fda.Date report sent to manufacturer.Date received by manufacturer.Type of report.If follow-up, what type? event problem and evaluation codes.

• 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: 7419453
• MDR Text Key: 105287843
• Report Number: 8030229-2018-00104
• 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,Followup
• Report Date: 10/21/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Distributor Facility Aware Date: 10/07/2019
• Device Age: 114 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 10/07/2019
• Supplement Dates FDA Received: 06/18/2018; 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1