MAUDE Adverse Event Report: SCOTTCARE VERSACARE; TELEMETRY

Device Problems Device Operates Differently Than Expected (2913); Data Problem (3196)

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

Event Type  malfunction  

Event Description

The telemetry server regularly and unexpectedly drops a patient from the list and reboots, resulting in loss of data and gaps in monitoring of patients in the cardiac rehab telemetry services department.The vendor was contacted about this issue and it was identified that the issue has been experienced at other sites as well.Scottcare is conducting testing to find out the underlying issues but thus far no final resolution has been achieved and the problems continue.

• Brand Name: VERSACARE
• Type of Device: TELEMETRY
• Manufacturer (Section D): SCOTTCARE
• MDR Report Key: 5297731
• MDR Text Key: 33643958
• Report Number: MW5058496
• Device Sequence Number: 1
• Product Code: DRG
• 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: 12/10/2015

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2015
• Type of Device Usage: N
• Patient Sequence Number: 1