MAUDE Adverse Event Report: JOERNS HEALTHCARE WECARE; PATIENT BED

Model Number WECC-WECARE-BASE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that per caregiver the pt fell out of the bed due the huge gaps between the mattress and edge of the bed frame.That the rails are not high enough.Pt is elderly and have dementia.The care giver was very upset that this happened twice in a row.Yesterday 11/2 (no service was submitted) and today 11/3.She stated that they only had this particular frame from joerns for maybe 30 days.Where as she had another frame previously for about 6 months and never had an issue like this.The caregiver is afraid that if the frame is not corrected properly.That if the pt falls a 3 time that might do serious injury to the pt or she might die behind the fall.At the time of the call the care giver stated that the pt is still on the floor.Complaint (b)(4) were entered into our system to have the bed returned for investigation.As of this writing, the bed has still not been returned.

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.

• 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; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 15959738
• MDR Text Key: 305266765
• Report Number: 3009402404-2022-00035
• 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: 12/02/2022

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: WECC-WECARE-BASE
• Device Catalogue Number: WECC-WECARE-BASE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/12/2022
• 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
• Patient Sex: Female