MAUDE MDR 6576678

MDR report key
6576678
Report number
6576678
Event key
0
Event type
3
Date of event
2017-04-14
Date received
2017-05-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANTAELECTRIC HOSPITAL BEDHILL-ROMFNJP1600I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-0501. O

Event Narratives#

D

Patient 1

AFTER PT RETURNED FROM AMBULATING TO THE RESTROOM, HE LEANED ON HIS HOSPITAL BED TO GET BACK INTO BED. THE BED THEN SLID BACK, AND HE FELL TO THE FLOOR ON HIS LEFT SIDE, SUSTAINING AN ABRASION ON HIS LEFT ELBOW. THE NEXT DAY, HE WAS UNABLE TO BEAR WEIGHT ON HIS LEFT LEG, AND IMAGING TESTS INDICATED AN ACUTE FRACTURE TO HIS LEFT HIP. SURGICAL INTERVENTION NOT RECOMMENDED AT THIS TIME. REFERRED TO A REHAB FACILITY FOR INITIAL PT. (B)(4) INSPECTED SUSPECTED DEVICE. DURING TESTING, BRAKES WERE LOCKED WITH CASTERS ADJUSTED IN VARIOUS POSITIONS, THEN A SIGNIFICANT AMOUNT OF PRESSURE WAS APPLIED TO SEVERAL LOCATIONS ON THE BED'S WEIGH FRAME SIDE (HEAD, INTERMEDIATE, AND FOOT SECTIONS) WHILE IN THE HIGH-LOW-HIGH AND LOW-HIGH AND LOW POSITIONS. SIMULATED A PATIENT ENTERING AND EXITING THE BED WITH THE BED IN THE LOWEST POSITION AND BRAKES IN THE LOCK POSITION. IT WAS CONCLUDED THAT WHEN THE BRAKE FUNCTION WAS ENGAGED, THE BRAKES WORKED AS DESIGNED. NO DEFECTS WERE FOUND FROM THE REPORTED COMPLAINT, AND NO REPAIRS WERE REQUIRED NOR RECOMMENDED.