MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PRISM 2000XP; CAMERA, SCINTILLATION (GAMMA)

Model Number PRISM 2000XP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2016

Event Type  malfunction  

Event Description

Upon daily quality check, camera malfunctioned.Unable to run automatic programs or movements without camera malfunction.

Event Description

Upon daily quality check, camera malfunctioned- the date and time did not correspond to the actual date and time.The date and time was 23 hours behind actual time.The device is approximately 10 years old.Unable to run automatic programs or movements without camera malfunction.Biomed logged in to service mode.They added the correct date and time, validated the device, and the camera was returned to service.It was determined that this issue occurred on the first of every month.The next month, no errors were found when the camera was validated.

• Brand Name: PRISM 2000XP
• Type of Device: CAMERA, SCINTILLATION (GAMMA)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 5636580
• MDR Text Key: 44568582
• Report Number: 5636580
• Device Sequence Number: 1
• Product Code: IYX
• 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,Followup
• Report Date: 04/05/2016,04/08/2016

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: No Information
• Device Model Number: PRISM 2000XP
• Other Device ID Number: CE#3409
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2016
• 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