MAUDE Adverse Event Report: MINDRAY DS USA, INC. BENIVISION CENTRAL STATION; MONITOR, PHYSIOLOGICAL, PATIENT

Model Number BENIVISION CENTRAL STATION

Device Problem Radiofrequency Interference (RFI) (2314)

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

Event Date 04/04/2018

Event Type  malfunction  

Event Description

Oncology med surg floor was having rf interference (telemetry) with all the rooms this afternoon.I called biomed and had them go take a look.They will call mindray in the morning to see if they can figure it out.

• Brand Name: BENIVISION CENTRAL STATION
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): MINDRAY DS USA, INC.; mahwah NJ 07430
• MDR Report Key: 7472403
• MDR Text Key: 107069095
• Report Number: MW5076874
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BENIVISION CENTRAL STATION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR