MAUDE Adverse Event Report: EPIC SYSTEMS CORPORATION; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Device Problems Failure to Transmit Record (1521); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/26/2018

Event Type  malfunction  

Event Description

Only two of my frequent blood pressures pulled over, then the monitor disassociated and stopped pulling over the vitals.This is probably the 4th time this has happened lately.

• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): EPIC SYSTEMS CORPORATION; 1979 milky way; verona WI 53593
• MDR Report Key: 7859725
• MDR Text Key: 119669429
• Report Number: 7859725
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA