MAUDE Adverse Event Report: JOERNS HEALTHCARE WECARE; PATIENT BED

Model Number WECC-WECARE-BASE

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and 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 per mt of bristol hospice, the patient was found unconscious on wednesday at 6:40pm with the lower half of his body on the floor and his neck was stuck between the mattress and the bed rail.He was transported to the hospital.Mt refused to disclose any more information due to hippa regulations.I advised she might receive a call regarding this incident.She stated that he is fine now.She had called in a service request to have the rails removed and placed a new order for a bed alarm to be delivered but they were rescheduled per fst notes.I canceled the service after the fact that she told me that the patient was injured and transported to the hospital.I created a new order for a new bed frame to be delivered and i created a pick up for the existing bedframe to be quarantined.There is a bed alarm order to be delivered as well.Original delivery 4501087801, pick up 8005342562, bed alarm 8005341013 and new delivery 8005342540.Complaint #(b)(4) and ra #(b)(4) has been entered into our system to have the products investigated.As of this writing, the products have not been returned.

• Brand Name: WECARE
• Type of Device: PATIENT BED
• 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: 15602541
• MDR Text Key: 301732100
• Report Number: 3009402404-2022-00026
• Device Sequence Number: 1
• Product Code: FNL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WECC-WECARE-BASE
• Device Catalogue Number: WECC-WECARE-BASE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• 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; Hospitalization
• Patient Sex: Male