MAUDE Adverse Event Report: MINDRAY DS USA, INC. BENEVISION CENTRAL STATION; TELEMETRY

Model Number BENEVISION CENTRAL STATION

Device Problems Failure to Transmit Record (1521); Radiofrequency Interference (RFI) (2314)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

Rooms were frequently reading rf interference on the mindray telemetry monitoring throughout the shift, especially between 0030-0100.Attempts were made to continue to monitor these patients, but this is difficult to do when the monitor is simply not transmitting.

• Brand Name: BENEVISION CENTRAL STATION
• Type of Device: TELEMETRY
• Manufacturer (Section D): MINDRAY DS USA, INC. ; mahwah NJ 07430
• MDR Report Key: 7472402
• MDR Text Key: 107069030
• Report Number: MW5076873
• 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: BENEVISION CENTRAL STATION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR