MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722028

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

When investigation is completed, a follow up report will be sent to fda.(b)(4).

Event Description

Philips was informed by a customer that while moving the c arm transverse a section of the echain fell off, landed on the patient and into the sterile field and contaminated it.The procedure was finished in a controlled way, the patient was not harmed in any way.

Manufacturer Narrative

A philips service engineer investigated the issue and found a faulty chain link from the cable caterpillar.He troubleshot the issue and found that the friction slide came loose, which caused the faulty chain link.He reinstalled the friction plate and chain link from the lateral motor which solved the issue.The service engineer could not reproduce the problem and we consider this as a onetime occurrence.The system was returned to the customer in working order.(b)(4).

Event Description

Philips was informed by a customer that while moving the c arm transverse a section of the echain fell off, landed on the patient and into the sterile field and contaminated it.The procedure was finished in a controlled way, the patient was not harmed in any way.

• Brand Name: ALLURA XPER FD20
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 4952912
• MDR Text Key: 23226483
• Report Number: 3003768277-2015-00063
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/07/2015

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: 722028
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• 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
• Patient Age: 65 YR
• Patient Weight: 91