MAUDE Adverse Event Report: PHILIPS PHILIPS INTEGRIS H; XRAY SYSTEM

Model Number ERROR

Device Problems Loss of Data (2903); Device Operates Differently Than Expected (2913)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

Films from biventricular permanent pacemaker placement and ablation unable to be sent to permanent storage.Philips service rep evaluated equipment and felt reason films would not be sent was due to the case file being corrupt.Films had to be deleted from equipment.Cath lab 7.

• Brand Name: PHILIPS INTEGRIS H
• Type of Device: XRAY SYSTEM
• Manufacturer (Section D): PHILIPS; andover MA
• MDR Report Key: 4387175
• MDR Text Key: 21772118
• Report Number: MW5039954
• Device Sequence Number: 1
• Product Code: IZF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERROR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 123