MAUDE MDR 6075445

MDR report key
6075445
Report number
1417592-2016-00113
Event key
0
Event type
3
Date of event
2016-09-28
Date received
2016-11-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KAREN TRUTSCH
Address
ONE MEDLINE PLACE MUNDELEIN IL 60060 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WHEELCHAIR, TRANSPORTMEDLINE INDUSTRIES INCINMWRX44972373615010011Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-0301. H; 2. R

Event Narratives#

N

Patient 1

THIS IS A REPORT FROM THE END USER'S WIFE WHO STATED HER HUSBAND GOT OUT OF THE CAR WITH HIS CANE AND SHE TOOK THE TRANSPORT CHAIR OUT OF THE CAR. SHE LOCKED THE TRANSPORT CHAIR AND STOOD ON THE SIDE OF THE CHAIR WHILE HER HUSBAND SAT DOWN IN THE CHAIR UNASSISTED. UPON SITTING DOWN IN THE TRANSPORT CHAIR THE CHAIR FELL BACK CAUSING THE CUSTOMER TO HIT HIS HEAD ON THE CEMENT GROUND IN THE PARKING LOT. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HE HAD A CT SCAN PERFORMED SHOWING THAT HE HAD A BRAIN BLEED. THE CUSTOMER WAS ADMITTED TO THE ICU FOR SIX DAYS AND THEN TRANSPORTED TO A SKILLED NURSING FACILITY FOR REHAB. THE CUSTOMER HAS A MEDICAL HISTORY OF HYPERTENSION AND WAS ON BLOOD PRESSURE MEDICATION AS WELL AS BLOOD THINNERS PRIOR TO THE FALL. FOLLOW UP INFORMATION WAS OBTAINED FROM THE CUSTOMER'S WIFE ON (B)(6) 2016. PER THE CUSTOMER'S WIFE, HER HUSBAND HAS MADE A DRASTIC IMPROVEMENT (SPECIFIC DETAILS OF IMPROVEMENT NOT SPECIFIED) SINCE SHE FIRST REPORTED THE FALL. THE WIFE STATED THAT THE BLEEDING IN THE CUSTOMER'S BRAIN HAS STOPPED AND HIS PHYSICIAN HAS RESTARTED THE BLOOD THINNERS THAT THE CUSTOMER IS ON FOR CARDIAC ISSUES. THE CUSTOMER IS STILL IN THE SKILLED NURSING FACILITY FOR PHYSICAL THERAPY, BUT WAS REPORTEDLY DOING 25% BETTER THIS WEEK THEN LAST WEEK AS HE STRENGTHENS HIMSELF WITH PHYSICAL THERAPY. A ROOT CAUSE HAS NOT BEEN DETERMINED AND WE CANNOT RULE OUT THE POSSIBILITY THAT THE SEATBACK FOLD-DOWN WAS NOT LOCKED IN THE UPRIGHT POSITION OF THE CHAIR. THOSE WHO DO NOT HAVE SUFFICIENT BALANCE AND AGILITY SHOULD NOT TRANSFER IN AND OUT OF THE CHAIR ON THEIR OWN PER MANUFACTURER INSTRUCTIONS. THE CUSTOMER'S WIFE CONFIRMED THAT THE CHAIR WAS NOT PROPERLY SUPPORTED IN THE BACK DURING PATIENT SEATING PER MANUFACTURER INSTRUCTIONS. WE HAVE NOT IDENTIFIED A MANUFACTURING DEFECT TO BE A CAUSE OR CONTRIBUTING FACTOR. HOWEVER, DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. NO ADDITIONAL INFORMATION WAS PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

CUSTOMER SAT IN TRANSPORT CHAIR AND FELL BACKWARDS HITTING HIS HEAD ON THE PAVEMENT.