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

Model Number	LC358S/CA358S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer is prone to concussions and may have experienced one due to the alleged incident.However, no medical treatment was sought.The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Alleges client was using the wand to move the chair when the chair suddenly shifted with a thump.The sudden drop was forceful enough to cause a concussion.
Additional Manufacturer Narrative
The device was returned and evaluated.The alleged condition (dropping with thump) could not be duplicated.
Event or Problem Description
Alleges client was using the wand to move the chair when the chair suddenly shifted with a thump.The sudden drop was forceful enough to cause a concussion.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• MDR Report Key: 7234492
• Report Number: 2530130-2018-00020
• Device Sequence Number: 949442
• Product Code: INO
• UDI-Device Identifier: 00606509400282
• UDI-Public: 00606509400282
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: LC358S/CA358S
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other