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 11/23/2018

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

Additional narrative: on 11/23/2018 customers reported they cannot admit/discharge any patients on some telemetry transmitters.These transmitters are monitored at a central station.The corresponding org receiver is org-9110a s/n 1253.During troubleshooting, it was determined that this org receiver did not function as intended.Thus, the receiver was sent into nk for evaluation and repaired as necessary.Service requested: repair.Service performed: evaluation.Investigation result: nka repair center evaluated the org receiver.The suspected issue that org-9110a s/n (b)(4) was causing the admit/discharge issue on the telemetry transmitters could not be duplicated.Receiver performed as expected and allowed cns to admit and discharge patients.The cause of the issue was not with the org receiver.Service history for this receiver shows no other incidents.Since the last reported incident on 12/3/2018, there has not been another occurrence of at this facility.The root cause is unknown.Corrected information: approximate age of device: incorrectly calcuated.Concomitant medical products: the cns was working in conjunction with the org which was monitoring the 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: 8187673
• MDR Text Key: 131137194
• Report Number: 8030229-2018-00477
• 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: 07/11/2019
• Device Age: 40 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CNSTRANSMITTER