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 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org is dropping its signal on multiple channels.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

H10: additional narrative: on (b)(6) 2018 customer stated the org receiver is showing signal loss.Customer requested repair services.A loaner was sent to customer.The alleged malfunctioned org receiver was never sent to nk.On (b)(6) 2019, customer stated that they were no longer having the signal loss issue and would be returning the loaner.The issue has not occurred since the initial event.Details was not provided.Service requested: repair.Service performed: loaner.Investigation result: service history for this org receiver shows no other incidents.Service history for this customer shows one other signal loss event reported on (b)(6) 2018 - ticket (b)(4).This ticket was reporting signal loss on the transmitter zm-531pa s/n (b)(6).The signal loss was on the v3 lead.Customer did not respond to additional inquiry on this event.The root cause could not be determined.There are no other tickets for this zm transmitter.The above history shows that these two events, together, were isolated incidents.Customer has not experience similar issues since.At this time, the root cause is unknown.Corrected information: f9.Approximate age of device: incorrectly calcuated.D11& c2 concomitant medical products: the cns was used in conjunction with the org which was monitoring transmitters.

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: 8187676
• MDR Text Key: 131137761
• Report Number: 8030229-2018-00472
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 02/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Distributor Facility Aware Date: 07/12/2019
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CNS TRANSMITTERS