MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number T14 TRANSMITTER

Device Problems Loss of Power (1475); Power Problem (3010)

Patient Problem No Information (3190)

Event Date 05/15/2019

Event Type  malfunction  

Event Description

Unpreventable device failure.Telemetry monitor box stop working.Found intermittent contact with aa batteries, thus losing power.Stretched and cleaned spring battery contact and verified no loss of power when batteries are installed.

• Brand Name: CARESCAPE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 465 pan american dr ste 11; el paso TX 79907
• MDR Report Key: 8691287
• MDR Text Key: 147777840
• Report Number: 8691287
• Device Sequence Number: 1
• Product Code: MHX
• 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: 05/16/2019

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 TRANSMITTER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2019
• Date Report to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33215 DA
• Patient Weight: 66