MAUDE Adverse Event Report: JOERNS HEALTHCARE WECARE BED; PATIENT BED

Model Number WECC-WECARE-BASE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/25/2022

Event Type  malfunction  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that per billie at bristol, the patient has fallen out of 5 times over the weekend.Facility advises fst did not install the correct side rails and he was going to install the correct rails today (b)(6) 2022.Because the incorrect rails were installed the rails would not hold the patient causing her to fall.She fall on top the fall pads so they helped preventing injury.**stat** service order: (b)(4) to switch out equip.Complaint #(b)(4) and ra #(b)(4) were entered into our system to have the units returned for investigation.As of this writing, the units have not been returned.

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.

• Brand Name: WECARE BED
• 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; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 15122967
• MDR Text Key: 302269693
• Report Number: 3009402404-2022-00018
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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
• Date Manufacturer Received: 06/28/2022
• 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
• Patient Age: 68 YR
• Patient Weight: 59 KG