MAUDE Adverse Event Report: CARESCAPE TRANSMITTER CARESCAPE TELEMETRY T14; TELEMETRY UNIT

Model Number T14

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

Pt was on a telemetry cardiac monitor.The pt had a cardiopulmonary arrest; however, a rhythm (heart) continued to show on the telemetry monitor.The staff verified that the correct monitor was on the pt, which it was.

• Brand Name: TRANSMITTER CARESCAPE TELEMETRY T14
• Type of Device: TELEMETRY UNIT
• Manufacturer (Section D): CARESCAPE
• MDR Report Key: 10817422
• MDR Text Key: 216194921
• Report Number: 10817422
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2020

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
• Device Operator: No Information
• Device Model Number: T14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• 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 Age: 51 YR
• Patient Weight: 57