MAUDE MDR 8206762

MDR report key
8206762
Report number
1027229-2018-00002
Event key
0
Event type
3
Date of event
2018-05-08
Date received
2018-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. RANDAL LANDRY
Address
5516 S.W. 1ST LANE OCALA FL 34474 US
Phone
352-352-3528
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WINCOVERO RECLINERWINCO MFG., LLCFRJ6Y486Y48-37R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-3101. H

Event Narratives#

D

Patient 1

REPORT MW5077640 WAS FILED BY FACILITY CLAIMING OUR RECLINER FAILED WHEN PATIENT TRIED TO PUSH HIMSELF UP TO GET OUT OF CHAIR, SIDE ARM LATCH MALFUNCTIONED AND SIDE PANEL SWUNG OPEN UNEXPECTEDLY, CAUSING PATIENT TO FALL ON FLOOR. PATIENT BROKE HIS HIP AND HAD TO BE TRANSFERED TO ANOTHER FACILITY FOR HIP SURGERY.PATIENT WAS UNATTENDED WHEN EVENT OCCURRED. IT WAS REPORTED AS MODEL#6240 INVERNESS 24-HOUR TREATMENT RECLINER. IT WAS IN FACT MODEL #6Y40 VERO RECLINER. INITIAL E-MAILS INDICATED THAT A WORK ORDER TO REPAIR THE CHAIR MAY HAVE ALREADY BEEN ISSUED FOR THE RECLINER PRIOR TO THIS ALLEGED INCIDENT, AND THEREFORE SHOULD HAVE BEEN REMOVED FROM SERVICE PER USER INSTRUCTIONS. FACILITY ALSO INDICATED THAT STAFF WERE NOT AWARE OF THE SWING ARM OPTION AND THEREFORE PROPER OPERATION ON THIS RECLINER WAS NOT UNDESTOOD, AS THEY WERE GIVEN THIS RECLINER BY A DIFFERENT DEPARTMENT. WINCO ENGINEER TRAVELED TO FACILITY TO EVALUATE CHAIR. HE CONCLUDED, BASED ON VISIBLE INSPECTION, THAT THE HINGE WAS DAMAGED (BENT) BY EXCESSIVE WEIGHT BEING APPLIED TO OPEN ARM PANEL, CONTRARY TO USER INSTRUCTIONS. THIS MOST LIKELY OCCURRED BEFORE THE INCIDENT AND LIKELY LEAD TO THE ALLEGED MALFUNCTION. NO DAMAGE TO LATCH WAS EVIDENT, AND IT OPERATED PROPERLY WHEN TESTED. WINCO WAS NOT GIVEN AN INCIDENT REPORT OR ALLOWED TO HAVE RECLINER RETURNED TO WINCO FOR COMPLETE EVALUATION. THE FACILITY WAS UNABLE TO GIVE US ANY INFORMATION ON THE OUTCOME OF THE PATIENTS SURGERY OR RECOVERY. THERE IS NO PHYSICAL EVIDENCE, VISUAL EVIDENCE, OR PRODUCT HISTORY TO INDICATE THAT THE SWING ARM LATCH FAILED. ROOT CAUSE IS EXCESSIVE WEIGHT BEING PLACED ON OPENED SWING ARM, BENDING THE HINGE; IMPROPER TRAINING AND IMPROPER MAINTENANCE.