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

Model Number FTGE2000

Device Problem Temperature Problem (3022)

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

Event Date 12/02/2020

Event Type  malfunction  

Event Description

The reported issue states that the unit was on the patient at the time the unit got hot.The patient was not harmed and no medical intervention was required.No additional information is available.

Manufacturer Narrative

The complaint states that the device got very hot while in use on a patient.There was no patient harm.The complaint device was returned for evaluation.Technical evaluation identified that the aluminum shielding was ripped off of the solder and the ecg block was damaged.The customer complaint was confirmed; however, the reported issue was not related to a previous service or repair.The root cause was determined to be that the device was most likely dropped, resulting in damage to the ecg block and torn off aluminum shields.The device was deemed unrepairable.An exchange was recommended.No additional information is available.

• Brand Name: GE APEX PRO CH TELEMETRY TRANSMITTER
• Type of Device: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 8200 west tower ave.; milwaukee WI 53223
• MDR Report Key: 11015851
• MDR Text Key: 241821936
• Report Number: 3007409280-2020-00053
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• PMA/PMN Number: K032369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: Health Professional
• Device Model Number: FTGE2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other