MAUDE Adverse Event Report: FXI STRYKER AIR II SYSTEM; PATIENT AIR MATTRESS

Model Number 999-3322SYS

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

Patient Problem Fall (1848)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was evaluated by the distributer and it operates to specifications.

Event Description

It was reported to the manufacturer by the end user, per the end user, "it was alleged that at approx 8:32am on 8/21 a nurse called a code rescue for a patient found on the floor.In the report it was noted that the patient attempted to get out of bed and fell.The head of the bed was in a 30 degree angle and the mattress was in the auto firm setting with the rails half down.The patient sustained bruising to the face above the left eye.Also it was told this patient is in comfort measures only." complaint (b)(4) was entered into our system.

• Brand Name: STRYKER AIR II SYSTEM
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): FXI; 1032 n 4th st.; baldwyn MS 38824
• Manufacturer (Section G): FXI; 1032 n 4th st.; baldwyn MS 38824
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 9135122
• MDR Text Key: 200500576
• Report Number: 3009402404-2019-00062
• 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: Other
• Type of Report: Initial
• Report Date: 09/30/2019

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
• Device Operator: Health Professional
• Device Model Number: 999-3322SYS
• Device Catalogue Number: 999-3322SYS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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