MAUDE Adverse Event Report: NKUS LAB RNS-6803-7450; REMOTE NETWORK STATION

Model Number	RNS-6803-7450
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their remote network system (rns) audible alarm is not sounding.No patient harm or injury was reported.Attempts to obtain additional information were made, but not provided.The customer will be sending this unit in for an exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that their remote network system (rns) audible alarm is not sounding.
Event or Problem Description
The customer reported that their remote network system (rns) audible alarm is not sounding.
Additional Manufacturer Narrative
The customer reported that their remote network system (rns) audible alarm is not sounding.No patient harm or injury was reported.Attempts to obtain additional information were made, but not provided.The customer will be sending this unit in for an exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

• Brand Name: RNS-6803-7450
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 14 bunsen; attn: shama mooman; irvine, ca CA 92618
• MDR Report Key: 9414074
• Report Number: 2032233-2019-00688
• Device Sequence Number: 2930401
• Product Code: MHX
• UDI-Device Identifier: 00851725007153
• UDI-Public: 00851725007153
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: RNS-6803-7450
• Device Catalogue Number: RNS-6803-7450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1