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 Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org is dropping its signal on multiple channels.No consequence or impact to the patient was reported.During follow up with the customer, the customer indicated that the issue resolved by a software downgrade.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 is dropping its signal on multiple channels.No consequence or impact to the patient.

Manufacturer Narrative

On (b)(6) 2018 customer stated org receiver could not get a signal after a software downgrade.When later contacted, customer stated the issue was resolved but did not provide details of the resolution.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: device was put into service on 8/25/2012.This device does not have a history of signal loss.Service history for this customer shows one signal loss incident at around the same time, notification # (b)(4).Under this notification, customer stated there was recent construction activity at the facility.Customer's third-party vendor had moved the antenna system during construction.This system was later reinstalled.Construction activities could cause a wireless signal interference.Further, re-installation of the antenna system could also cause performance issues.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.Due to customer stating that the issue had resolved, and no information could be provided, the root cause of the reported issue could not be determined.Customer's service history shows this issue has not re-occurred since this (b)(6) 2018.

Event Description

The customer reported that the org is dropping its signal on multiple channels.No consequence or impact to the patient.

• 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: 8198077
• MDR Text Key: 131500510
• Report Number: 8030229-2018-00496
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2019
• Distributor Facility Aware Date: 07/22/2019
• Device Age: 106 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2019
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1