MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722005

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

The customer reported that the cable hose hit against the frontal live sub-monitor in the examination room.This live sub monitor came loose and kept hanging on the ground wire cable, so it did not fall.The customer did not report any injury on patient or bystander.

Manufacturer Narrative

Philips has investigated this complaint and found that the monitor is attached on top, which is standard, but facing the back of the monitor suspension.The philips field service engineer noticed that the cable hose gets caught behind the monitor, most likely pulling the screws loose that keep the glider rods in place, and resulting in the monitor falling.The sub monitors on top of the flexvision frame are mounted on a suspension arm (glider rods) and secured with a set of screws.Over time, due to used materials and forces on the suspension arm because of collisions of monitor and cable hoses, these screws may lose their torque.The field service engineer reattached the monitor to its support, and added tie wraps for extra security.Based on trending analysis, we conclude that there is no exceptional replacement rate for this part.(b)(4).

• Brand Name: ALLURA XPER FD10/10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5245669
• MDR Text Key: 32225065
• Report Number: 3003768277-2015-00100
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

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: Health Professional
• Device Model Number: 722005
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1