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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not made available for evaluation at this time.Should further information or the device become available, a follow-up report will be issued.
Event or Problem Description
Alleges user had to call the fire department to get them out of the chair because it was stuck in recline.
Additional Manufacturer Narrative
The replaced parts from the fst were returned for evaluation.The alleged condition could not be duplicated.
Event or Problem Description
Alleges user had to call the fire department to get them out of the chair because it was stuck in recline.
Event or Problem Description
Alleges user had to call the fire department to get them out of the chair because it was stuck in recline.
Additional Manufacturer Narrative
An fst evaluated the device and replaced the control box, motor, and hand control.The unit is working properly.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10276032
• Report Number: 2530130-2020-00069
• Device Sequence Number: 19100877
• Product Code: INO
• UDI-Device Identifier: 00606509400299
• UDI-Public: 00606509400299
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/19/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020; 07/10/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/10/2020; 08/24/2020
• 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