MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EPIQ 7; PROBE, TEE

Model Number 989605386721

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Event Description

The patient was sedated and prepared for a transesophageal echocardiography (tee).The probe was passed and the machine being used lost function.The machine was shut down and rebooted but unable to obtain echo pictures.The probe was removed from the patient and the machine was switched out.The patient required additional medication and the probe was passed again.Machine was checked out by philip's service a few hours after the occurrence and they determined the new tee probe was faulty.A new probe was onsite the same day.There was no patient harm.Manufacturer response for tee probe, (brand not provided) (per site reporter).Philip's service a few hours after the occurrence and determined the new tee probe was faulty.I do not have a field report.

• Brand Name: EPIQ 7
• Type of Device: PROBE, TEE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 6948051
• MDR Text Key: 89279392
• Report Number: 6948051
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 989605386721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC MONITORING
• Patient Age: 29 YR