MAUDE Adverse Event Report: FXI PROCAIR PLUS MATTRESS; PATIENT AIR MATTRESS

Model Number 222-3684

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, caretaker changing sheets while patient was on equipment and during the process patient moved to the side to quickly and fell off the equipment.The patient was taken to the hospital and sustained injuries to the right side of the body.Complaint# (b)(4) was entered into our system.

• Brand Name: PROCAIR PLUS MATTRESS
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): FXI; 1032 n 4th st.; baldwyn, ms
• Manufacturer (Section G): FXI; 1032 n 4th st.; baldwyn, ms
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, tx ; 8260270331
• MDR Report Key: 9741204
• MDR Text Key: 180530501
• Report Number: 3009402404-2020-00017
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 222-3684
• Device Catalogue Number: 222-3684
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 82