MAUDE MDR 7801580

MDR report key
7801580
Report number
MW5079248
Event key
0
Event type
3
Date of event
2018-08-08
Date received
2018-08-20
Adverse event
0
Product problem
0
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0WHEELCHAIR LIFTPERMANENTLY PROMOTED WHEELCHAIR PLATFORM LIFTHARMAR MOBILITY,LLCPCEAL500I Y
1WHEELCHAIR LIFTPERMANENTLY PROMOTED WHEELCHAIR PLATFORM LIFTHARMARPCEAL500I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-200

Event Narratives#

D

Patient 1

I HAVE A DANGEROUS WHEELCHAIR LIFT BECAUSE THE SELF RETRACTING RATCHETS ALLOW THE WHEELCHAIR TO COME OFF BECAUSE THEY FAIL TO SELF-TIGHTEN AND SOMEONE IS GOING TO GET KILLED WHEN A WHEELCHAIR COMES FLYING OFF ONE OF THESE HARMAR AL500. THEY NEED TO BE RECALLED AND RETROFITTED WITH A MUCH STRONGER SELF RETRACTING MECHANISM LIKE I'VE SEEN IN A RENTAL VAN. THEY COME WITH FLIMSY WEAK RATCHETS THAT YOU HAVE TO MANUALLY TIGHTEN AND EVEN THEN THEY ARE PRONE TO ALLOW THE WHEELCHAIR TO COME OFF EVEN WHEN YOU SLOW DOWN AND GO OVER A BUMP. I PAID (B)(6) TO MOBILITY WORKS FOR THIS PIECE OF JUNK AND IT IS A DRIVER HAZARD. I'M A RETIRED DIR OF ENGINEERING AND FORMER ELECTRONICS DESIGN ENGINEER, SO I'M NOT JUST A DISGRUNTLED CUSTOMER. I ASSUME MOBILITY WORKS WILL FIX THE PROBLEM AND PAY FOR RETROFIT, BUT REGARDLESS, THESE PIECES OF JUNK SHOULD NOT BE ALLOWED ON THE STREETS. WEBSITE IS (B)(6). INCIDENT LOCATION: (B)(6); THIS IS MY HOME ADDRESS. PRODUCT DETAILS: 400 POUND POWER WHEELCHAIR LIFT THAT INSTALLS INSIDE THE RECEIVE HITCH OF A TRUCK (IN MY CASE, A (B)(6)). MFR ADDRESS: (B)(4). RETAILER: (B)(6). RETAILER STATE: (B)(6). THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. YES, YOU MAY INCLUDE MY REPORT WITH ANY ATTACHMENTS ON (B)(4). I CERTIFY THAT I HAVE REVIEWED THE REPORT AND THAT THE INFO PROVIDED IN THIS REPORT IS TRUE AND ACCURATE TO THE BEST OF MY KNOWLEDGE, INFO, AND BELIEF: YES. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).