MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC ZIPPIE ZM310; POWERED WHEELCHAIR

Model Number	EIPW22
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical customer service contacted (b)(6), which provides care for the end user, to gather more information regarding this incident.Contact was made with their representative (b)(6).(b)(6) stated the caregiver was pushing the user in the grass and came across an uneven spot and caused the chair to tip forward.The caregiver grabbed the user so he would not fall out, which he did not, however in doing so the patient fractured his leg.(b)(6) stated the user has osteopenia (brittle bone).There were no allegations of malfunction or defect made by the caregiver against the subject wheelchair.According to the description of the complaint as given by (b)(6) at (b)(6), the near fall was accidental.Since the chair was ordered without a chest harness, (b)(6) is looking into obtaining one to offer support to the end user in his chair.Sunrise medical deems this incident as accidental and no further investigation will be performed by sunrise medical.
Event or Problem Description
Stephanie with the user's school called and stated the user fell out of his chair.She stated the chair tipped a little and the user fell out and fractured his leg.

• Brand Name: ZIPPIE ZM310
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7545258
• Report Number: 2937137-2018-00006
• Device Sequence Number: 16459204
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other Caregivers
• Device Model Number: EIPW22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 16