MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GE APEX PRO CH TELEMETRY TRANSMITTER; MODIFICATION TO: APEXPRO TELEMETRY SYSTEM

Model Number FTGE2000

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

Reported issue: the device was overheating.There was no patient harm.The complaint device was returned for evaluation.Technical evaluation identified physically damaged casing, defective case and a positive pin in the case making the device overheat.The ge apex pro ch telemetry transmitter service kit #1 was replaced.The board was connected onto a new case and the device was left running overnight; no overheating or errors were given.The unit was tested on our central station and performed to oem specifications.The customer complaint was confirmed; however, the failure identified was not related to a previous service or repair.The root cause was determined to be that the case was defective and causing the board to overheat.No additional information is available.

Event Description

The device was overheating.There was no patient harm.

• Brand Name: GE APEX PRO CH TELEMETRY TRANSMITTER
• Type of Device: MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 8200 west tower ave.; milwaukee WI 53223
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: robert mitchell ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 12188673
• MDR Text Key: 264269295
• Report Number: 3007409280-2021-00011
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K032369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FTGE2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1