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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS EPIQ 7 PROBE, TEE Back to Search Results
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.
 
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Brand NameEPIQ 7
Type of DevicePROBE, TEE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key6948051
MDR Text Key89279392
Report Number6948051
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received10/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605386721
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2017
Event Location Hospital
Date Report to Manufacturer09/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
Treatment
CARDIAC MONITORING
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