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

Model Number ORG-9100A

Device Problems Radio Signal Problem (1511); Communication or Transmission Problem (2896)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org went into signal loss on all 8 tiles.They attempted to reset the unit by pressing the initialization button.They sent the unit in for repair and the cpu board pcb unit was replaced to resolve the issue.There was no patient harm was reported.

Event Description

The customer reported that the org went into signal loss on all 8 tiles.

Manufacturer Narrative

Details of complaint on 12/6/2017 customer reported that 8 tiles were experiencing communication loss.The device model and serial # were not provided.Customer attempted to power cycle the corresponding org receiver to resolve the issue but there was no change.Customer attempted to "reset" the receiver by pressing the initialization button.Service requested: repair.Service performed: repair.Investigation result: nka repair center replaced part # ur-3981 cpu board to resolve the issue.The root cause of the failure was not determined.Trending for part # ur-3981 shows two other incidents of where ur-3981 was replaced: 300023903 - reported date 8/3/2015.300024178 - reported date 8/5/2015.There have been no ur-3981 failures in 2017 or since then.Additional information: b4.Date of this report; f6.Date user facility/importer became aware of the event; f7.Type of report; f11.Date report sent to fda; f13.Date report sent to manufacturer; g4.Date received by manufacturer; g7.Type of report; h2.If follow-up, what type? additional information, device evaluation; h3.Device evaluated by manufacturer?; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.

Event Description

The customer reported that the org went into signal loss on all 8 tiles.

• 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: 7162845
• MDR Text Key: 96373866
• Report Number: 8030229-2018-00001
• 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: 10/07/2019

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2019
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1