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

Model Number 722003

Device Problems Loose or Intermittent Connection (1371); Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips received a complaint from a customer in which they explained the following problem: the customer moved the c-arm by pushing the control, when she lifted her finger off the control panel, the c-arm momentarily kept moving.The doctor felt that the safety glass was pushed by the c-arm too close to him and backed away but the sheath came loose as he did this.He then had to pull it out and press on the groin to stop the bleeding.No patient or user harm was reported due this issue.

Manufacturer Narrative

A philips field service engineer found that the table side operation joystick was sticking and therefore returning slowly to its zero position.This caused the movement to continue after it had been released by the customer.The fse cleaned the geo module mechanically, after which no further faults occurred.We do not consider this to be a structural issue.(b)(4).

• Brand Name: ALLURA XPER FD10
• 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 Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 5047215
• MDR Text Key: 25357649
• Report Number: 3003768277-2015-00073
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2015
• 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