MAUDE Adverse Event Report: JOERNS HEALTHCARE STRYKER SYSTEM; PATIENT AIR MATTRESS

Model Number 9993322SYS

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

Patient Problem Skin Erosion (2075)

Event Date 04/19/2021

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that patient said there was not enough air flow in the mattress initially, it was taken out of service but the evaluation didn't show anything wrong.It was then put back into service.The patient then developed a sacral pressure injury.Mattress has been removed from service pending investigation.(b)(6) stated she was waiting from stryker to see if stryker wanted to test and hadn't heard anything.Agiliti has went ahead with the investigation.Complaint #(b)(4) was entered into our system.

• Brand Name: STRYKER SYSTEM
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; 2100 design road; arlington TX 76014
• Manufacturer Contact: mackenzie bay ; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 12030212
• MDR Text Key: 257160131
• Report Number: 3009402404-2021-00007
• 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: 06/19/2021

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: No Information
• Device Model Number: 9993322SYS
• Device Catalogue Number: 9993322SYS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/19/2021
• 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): Other