MAUDE Adverse Event Report: PHILIPS HEALTHCARE MD ELEVA FD; SYSTEM, X-RAY, STATIONARY

Model Number 708038

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/25/2017

Event Type  Death  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that at the end of a procedure the patient needed a cardiac massage because the patient had a cardiac arrest, the tabletop had too much flexibility and the medical staff had to hold the patient in place in order to treat the patient.Philips was not informed about any patient harm.

Manufacturer Narrative

During the investigation of this complaint it was confirmed that the customer had difficulties performing cardiopulmonary resuscitation (cpr) to a patient due to the flexibility of the system¿s table.A doctor had to hold the end of the table during the cpr.Philips was confirmed by a healthcare professional of the hospital that the system did not contribute to the outcome of the patient.To allow x-ray to pass through the table and make all projections possible the md eleva system has been designed with a thinner tabletop.This results in a more flexible tabletop.To perform cpr, the md eleva has a cpr support that is placed under the table in order to provide stability during cpr.

• Brand Name: MD ELEVA FD
• Type of Device: SYSTEM, X-RAY, STATIONARY
• 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: 6766518
• MDR Text Key: 82010281
• Report Number: 3003768277-2017-00071
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050151
• 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,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 708038
• Device Catalogue Number: 708038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 07/26/2017; 07/26/2017
• Supplement Dates FDA Received: 12/13/2017; 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2013
• 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