FDA Adverse Event Malfunction Summary report: N

BIODEX MEDICAL SYSTEMS

MDR report key: 5323213 · Received December 16, 2015

Report

Report Number: 2431414-2015-00001
Event Type: Malfunction
Date Received: December 16, 2015
Date of Event: November 5, 2015
Report Date: November 6, 2015
Manufacturer: BIODEX MEDICAL SYSTEMS, INC.
Product Code: FPO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: 2

Narratives

Additional Manufacturer Narrative · 1

BIODEX RECEIVED THE MEDWATCH FORM FROM THE USER FACILITY ON 11/16. BIODEX RECEIVED THE FDA MAILED REPORT ON 12/8/2015. WE TRIED CONTACTING (B)(6). THEY SAID A CASTER CAME LOOSE AND CAME OFF THE STRETCHER. THE STRETCHER FLIPPED WITH THE PT ON THE STRETCHER. (B)(6) TOLD US THAT THE OTHER CASTERS WERE LOOSE. HE ORDERED A NEW CASTER AND INSTALLED IT INO THE STRETCHER. AT THE SAME TIME HE TIGHTENED THE OTHER CASTERS. HE TLD US HE THEN CHECKED THE OTHER MRI STRETCHER THEY HAVE AND MADE SURE THOSE CASTERS WERE ALL TIGHT. HE DID NOT KNOW IF THEY HAD USED THE RESTRAINING STRAPS OR HAD THE SIDE RAILS UP ON THE STRETCHER. HE TOLD US HE THOUGHT THEY WOULD NOT HAVE HELPED THE PT. DAVID BROWN TOLD US THAT THEY NEVER PERFORMED ANY PERIODIC MAINTENANCE OR CHECKED THE STRETCHER IN THE YEARS THEY HAVE HAD THEM. THEY WILL PERIODICALLY CHECK THE CASTERS IN THE FUTURE. THE INSTRUCTION MANUAL SAYS TO PERIODICALLY CHECK THAT THE CASTERS HAVE NOT LOOSENED. TIGHTEN IF REQUIRED.

Description of Event or Problem · 1

WHEN PT WAS PLACED ON MRI STRETCHER, THE WHEEL FELL OFF AND THE PT FELL TO THE FLOOR FACE DOWN. HE WAS TAKEN TO THE ED FOR EVALUATION AND IMAGING STUDIES WERE COMPLETED, WHICH WERE NEGATIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
832128	BIODEX MEDICAL SYSTEMS	MRI STRETCHER	FPO	BIODEX MEDICAL SYSTEMS, INC.	240-110

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR