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

Model Number	LC358M
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "date of event" was not provided.The device has not been made available for evaluation at this time.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Alleges sliding off chair twice and hit the floor.Also, alleges chair in full standing position, the control wire got disconnected when the seat was moving upwards.Alleges chair stopped working and consumer was trapped in a tilted position and slid off the chair.
Additional Manufacturer Narrative
The customer was refunded and the device was removed from use by a field service technician.
Event or Problem Description
Alleges sliding off chair twice and hit the floor.Also, alleges chair in full standing position, the control wire got disconnected when the seat was moving upwards.Alleges chair stopped working and consumer was trapped in a tilted position and slid off the chair.

• 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: 7968790
• Report Number: 2530130-2018-00145
• Device Sequence Number: 16564623
• Product Code: INO
• UDI-Device Identifier: 00606509400251
• UDI-Public: 00606509400251
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 05/22/2019

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: LC358M
• 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: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 05/23/2019
• 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: Hospitalization