MAUDE Adverse Event Report: INVAMEX INVACARE SOLARA 3G TILT-IN-SPACE WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number SOLARA3G

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Photographs of the chair were provided, which indicate that the frame is bent such that the chair is not seated properly on the left tilt slide, and the upper tilt locking collars are missing from both tilt slides.Currently, the underlying cause of the issue is undetermined.The provider indicated that there is no history of repairs for this chair.It was requested that the chair be returned to invacare for further evaluation.Should additional information become available, a supplemental record will be filed.

Event Description

The provider reported that while the patient was being pushed up a vehicle ramp in the solara3g wheelchair, the frame of the chair became unhinged from the base, causing the patient to fall out of the chair.The patient's caregiver added that the chair was in its normal upright position.She also stated that the patient was moving a lot, which made it difficult to push her up the ramp.She alleged that the upper tilt locking collars came loose from the chair, and the patient fell.The patient was seen at the hospital, diagnosed with a fractured hip, given pain medication, and sent home.

Event Description

The provider reported that while the patient was being pushed up a vehicle ramp in the solara3g wheelchair, the frame of the chair became unhinged from the base, causing the patient to fall out of the chair.The patient's caregiver added that the chair was in its normal upright position.She also stated that the patient was moving a lot, which made it difficult to push her up the ramp.She alleged that the upper tilt locking collars came loose from the chair, and the patient fell.The patient was seen at the hospital, diagnosed with a fractured hip, given pain medication, and sent home.

Manufacturer Narrative

The evaluation of the wheelchair was completed on 02/03/2020.It was observed that the chair was missing hardware that could render the seat unstable in certain tilt configurations or during adjustments.The tilt lockout collars were not present at the ends of the gear rack tubes/tilt slides, so the rocker tubes were capable of disengaging from the gear racks when the seat was returned to a fully upright position.In this condition, only the front of the seat frame is connected to the base, which is likely what the provider had described as becoming unhinged.The solara3g user manual warns, "after any adjustments, repair or service and before use, make sure all attaching hardware is tightened securely and locking collars are positioned at the same position on the tilt slide." the device history record for this wheelchair was reviewed, and no issues or reworks were noted; the device met specifications prior to distribution.During final inspection, it was visually and functionally confirmed that the tilt locking collars were correctly adjusted.The function of the tilt lockout collars is to allow users to limit the tilt angle of the chair.They are not a structural part of the chair.Even if the tilt collars are not present, the seat will not move unless both tilt locking mechanisms are disengaged.When the device is operating as intended, the trigger release levers must be held in to disengage the gear assemblies from the gear racks, which allows the chair to tilt.Once the levers are released, the gears reengage, returning the tilt function to its default locked position.Unfortunately, due to the condition of the returned wheelchair, the tilt function was unable to be tested properly.It appeared that the rear crossbrace may have been slightly bent, causing the chair frame to be askew.The left rocker tube did not align with the gear rack, so the left gear assembly remained disengaged from the gear rack.The right gear assembly was properly engaged within the gear rack.However, even when the right trigger release lever was squeezed to disengage the gear assembly, the chair was very difficult to tilt.Based on this information, the most likely cause of the incident is that the chair's tilt-in-space feature was engaged while the chair was being pushed up the ramp.This goes against the instructions within the solara3g user manual, which state to place the wheelchair on a level surface, engage both wheel locks, inform the occupant of the wheelchair that the wheelchair is about to be tilted and remind them to lean back before initiating tilt.Note: the serial number originally provided was incorrect.Serial number (d4) and device manufacturer date (h4) have been updated to reflect the correct information.

• Brand Name: INVACARE SOLARA 3G TILT-IN-SPACE WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas
• MDR Report Key: 9371213
• MDR Text Key: 167861702
• Report Number: 9616091-2019-00029
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOLARA3G
• Device Catalogue Number: SOLARA3G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75