MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRIGHTVIEW; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number 50084759

Device Problem Mechanical Problem (1384)

Patient Problem Bruise/Contusion (1754)

Event Date 04/28/2011

Event Type  malfunction  

Event Description

The patient was lying on the imaging table having a nuclear stress test.The patient's arm became wedged between her chest and the camera.The technologists were unable to reposition the patient's arm or to back the camera off of the patient's arm.The technologist used the manual release on the table to pull the table and patient out of the scanner.The patient sustained minor bruising to the arm.

• Brand Name: BRIGHTVIEW
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner road; cleveland, OH 44143
• MDR Report Key: 5892937
• MDR Text Key: 52628227
• Report Number: 5892937
• Device Sequence Number: 1
• Product Code: KPS
• 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: Patient
• Type of Report: Initial
• Report Date: 05/04/2011,08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 50084759
• Other Device ID Number: ASSET #F10450
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2011
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 82