MAUDE Adverse Event Report: INVACARE TAYLOR STREET M51P BLUE BASE W/MK5 NX SPJ+ 9153642087; WHEELCHAIR, POWERED

Model Number M51P

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395); Device Slipped (1584); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It was reported that the joystick clip was broken off by physical abuse of the end user running into things, in turn creating the alleged malfunctions of unintended motion and a 9 flash error code and the injury allegation of a pelvis spiral fracture.Should additional information become available a supplemental record will be filed.

Event Description

Dealer states they are getting a 9 flash code and the upper joystick cable will not stay locked into the joystick, clip was broken off so the 9 pin cable comes out.Provider states the chair still moves even with the 9 flash error code.Provider states the consumer alleges the chair took off without command and drove into his bed, causing a spiral fracture on his pelvis, consumer went to the emergency room at the va afterwards.Provider states the screws on the plug support of the on board charger have broken off, charger does still work.No additional information provided.Update from consumer affairs on 4/26/2016: provider states the end user runs into things with the chair at times and broke off the clip that holds the joystick cable in so it wiggles and comes off at times causing chair to stop if it comes out.Dealer ordered parts to service and fix the chair and no return is anticipated due to repair.Dealer does not believe it is a manufacturer defect and feels it is the end user running into stuff breaking the parts.No further information provided.

• Brand Name: M51P BLUE BASE W/MK5 NX SPJ+ 9153642087
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5614302
• MDR Text Key: 43849713
• Report Number: 1525712-2016-01335
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization