MAUDE Adverse Event Report: PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 708032

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.(b)(4).

Event Description

The customer reported that during a case the monitor trolley suddenly lurched forward and was caught by a member of staff before it hit a patient lying on the table of the md eleva.One of the brackets that holds the wheel for the monitor trolley had snapped.No patient or user was harmed due to this issue.

Manufacturer Narrative

Philips was not able to investigate the issue further because the sheared bracket is no longer available.A keyword search for similar occurrences did not show any results.Combined with the fact that the bracket is not available for further investigation, no root cause analysis will be performed.(b)(4).

• Brand Name: MULTIDIAGNOST ELEVA
• 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: 5343867
• MDR Text Key: 35378034
• Report Number: 3003768277-2016-00004
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023441
• 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: 12/09/2015

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: 708032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2005
• 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: 50 YR