MAUDE MDR 7533699

MDR report key
7533699
Report number
1834066-2018-00001
Event key
0
Event type
3
Date of event
2017-02-18
Date received
2018-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CHRISTINE MILLER
Address
2601 INDUSTRIAL PARKWAY ELKHART IN 46516 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MECHANICAL CHAIR/TRANSPORT CHAIRMECICAL RECLINERCHAMPION MANUFACTURINGKMN547FL06-TS54 SERIES RECLINERN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-2201. O

Event Narratives#

N

Patient 1

REVIEW OF OPERATOR MANUAL THAT ACCOMPANIED THE CHAIR PAGE 7 STATES PROPER IN-SERVICE PROCEDURES. PAGES 16 AND 17 CONTAIN A CAUTION THAT STATES: CAUTION: THIS CHAIR HAS MOVING PARTS THAT MAY CREATE PINCH POINTS. WORK CAREFULLY. HAVE YOUR HANDS CLEAR OF THE MECHANISM WHEN YOU MOVE THE CHAIR FROM ONE POSITION TO ANOTHER. IN ADDITION TO THE INITIAL SHIPMENT OF CHAIRS, THERE WERE FOUR ADDITIONAL SHIPMENTS OF SIMILAR CHAIRS RECEIVED AT THIS FACILITY SINCE THIS SPECIFIC CHAIR WAS PURCHASED. ALL HAD OPERATOR MANUALS NOTING THE PROPER OPERATION OF THE RECLINERS, INCLUDING DIRECTIONS FOR STAFF TO SAFELY ASSIST A PATIENT IN POSITIONING THE CHAIR IF THEY NEED ASSISTANCE. THE MANUAL ALSO CONTAINS CAUTIONS ABOUT KEEPING YOUR HANDS CLEAR OF THE MECHANISM. THE IN-SERVICE PACKET ALSO COMES WITH A VIDEO SHOWING SAFE OPERATION OF THE CHAIR BY A PATIENT AND BY STAFF ASSISTING THE PATIENT. REVIEW OF SERVICE PARTS AND SALES ACTIVITY AT THIS PARTICULAR CLINIC SHOWS NO SIGNIFICANT REPAIR TO THE MECHANICAL PARTS OF THEIR CHAIRS. ROUTINE FOLLOW UP CALL NOTED CHAIRS OPERATING PROPERLY AND THERE WERE NO QUESTIONS OR CONCERNS FROM STAFF. ON 11 APRIL 2018, CHAMPION VERIFIED WITH THE FACILITY THAT THEY NO LONGER HAD SERIAL (B)(4). THE FACILITY REPRESENTATIVE SAID HE THOUGHT THEY DISCARDED THE CHAIR WHEN THEY PURCHASED ALL NEW CHAIRS FROM CHAMPION.

D

Patient 1

A TECHNICIAN WAS ASSISTING A PATIENT ONTO A RECLINER. THE ACTUATOR HANDLE WAS PULLED TO RELEASE THE FOOTREST AND THE TECHNICIAN'S HAND WAS IN THE PATH OF THE OPENING FOOTREST. THE TECHNICIAN PINCHED HIS LEFT RING FINGER IN THE MECHANISM OF THE CHAIR, RESULTING IN A SKIN TRAUMA OF LACERATION 2 CM SQUARE IN SIZE.