MD ELEVA FD

MDR report key: 6766518 · Received August 4, 2017

Report

Report Number: 3003768277-2017-00071
Event Type: Death
Date Received: August 4, 2017
Date of Event: July 25, 2017
Report Date: July 26, 2017
Manufacturer: PHILIPS HEALTHCARE
Product Code: KPR
PMA / PMN Number: K050151
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
549512	MD ELEVA FD	SYSTEM, X-RAY, STATIONARY	KPR	PHILIPS HEALTHCARE	708038

Patients

Seq	Age	Sex	Outcome	Treatment
1