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

Model Number PLR990IL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been made available for evaluation.Should the device become available or further information become available, a follow-up report will then be issued.

Event Description

Provider alleges the back broke off of the chair and the end user allegedly fell out.

Event Description

Provider alleges the back broke off of the chair and the end user allegedly fell out.

Manufacturer Narrative

The device was returned and evaluated.The back did not break off.The visual and mechanical evidence indicates the kd securement hardware was not utilized during back assembly.Improper/incomplete back installation post final release.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 11945993
• MDR Text Key: 254530485
• Report Number: 2530130-2021-00055
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401203
• UDI-Public: 00606509401203
• Combination Product (y/n): N
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: PLR990IL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other