MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES QUICKIE 2; MANUAL FOLDING WHEELCHAIR

Model Number EIQ2X

Device Problems Break (1069); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Pain (1994); Physical Entrapment (2327)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Sunrise medical's regulatory specialist contacted the end user on (b)(6) 2017 to gather more details about the incident.The end user stated that after he received the longer axle pins from wi medical back in (b)(6), he had not had any problems with the chair.He also stated that he is still having pain in his arm and had an appointment with his doctor the morning of (b)(6) 2017.The end user stated that the doctor could not determine what the injury was and prescribed an x-ray and mri.A qa inspection was performed by sunrise medical on a similar wheel configuration and it was found that the size axle that was originally used on the chair will lock in place properly and has passed the qa inspection, performing to specification.However, if the wheel is not mounted correctly, by inserting the axle all the way into the hub, it will not lock to the receiver and the wheel will come off of the chair.To assist the end user in ensuring that he is properly mounting and locking the wheels in place, the longer axle pins were provided and the issue was resolved.

Event Description

On (b)(6) 2017 the end user reported that he had contacted sunrise medical customer service on (b)(6) 2017 informing that the axle pins on chair were too short, however, no adverse event was reported at that time.The end user is now stating that back in (b)(6), prior to his initial call, he was in his chair in his kitchen when the left axle "came apart" on wheel, which then led to the wheel falling off completely.He claimed this caused him to fall onto the ground in which he noticed his arm/hand was trapped bent underneath the chair.The end user stated that since the incident occurred, his arm and wrist have been hurting and has been getting worse.

• Brand Name: QUICKIE 2
• Type of Device: MANUAL FOLDING WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 7119624
• MDR Text Key: 94932540
• Report Number: 9616084-2017-00013
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIQ2X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 70