MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR

Model Number	LC358XL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.If the device or further information becomes available, a follow-up report will then be issued.
Event or Problem Description
Alleges chair continued past point when button released causing a fall.Alleges customer was unable to get up and was assisted by fire department and paramedics.
Additional Manufacturer Narrative
The device was repaired in the field.The technician discarded the old parts immediately after repairing.Therefore, there are no parts to evaluate.The device is working properly.
Event or Problem Description
Alleges chair continued past point when button released causing a fall.Alleges customer was unable to get up and was assisted by fire department and paramedics.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 8090917
• Report Number: 2530130-2018-00165
• Device Sequence Number: 13817680
• Product Code: INO
• UDI-Device Identifier: 00606509400299
• UDI-Public: 00606509400299
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: Lay User/Patient
• Device Model Number: LC358XL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: Other
• Patient Weight: 181