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

Model Number 9993322SYS

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that customer alleges per the below, agiliti has received notification that zsx 1726 (b)(4) and zsy 1731 (b)(4) were reported to have been involved in an equipment incident.There was no injury to the patient.Agiliti will perform testing of these units.This is just a fyi, and nothing further is needed.On (b)(6) 2022, (b)(6), materials manger, reports stryker ii blower sparked while a student inter was handling the equipment.Gloves worn by student intern reportedly made contact with sparks from equipment.No on was harmed in the incidend zsx 176 (blower) was being used zsy 1731 (mattress).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: 15568297
• MDR Text Key: 306544175
• Report Number: 3009402404-2022-00025
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9993322SYS
• Device Catalogue Number: 9993322SYS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/07/2022
• 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): Other