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

Model Number UCXTBED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that at 1:46pm on 20-apr-22, (b)(6) emailed to report an incident that allegedly involved the following product or device: ultracare xt bed, and deluxe assist handle for ucxt beds.Kris boyd reported that the following occurred in the morning on (b)(6) 2022: customer reported the positioning devices on the beds are injuring residents.They reported a resident slid their head across and it rubbed against the holder that is on the device that holds the bed controller, causing a large laceration.The incident was reported in regards to one bed, however customer is concerned that all of their beds are now presenting a risk/danger to residents due to sharp edges.The following injuries allegedly occurred: resident had a large laceration that required sutures.Kris boyd reported that the injured party was treated at a hospital/clinic and released.Complaint #: (b)(4) and ra #84089535 was entered into our system to have the bed frame returned for investigation.As of this writing, the units have 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: UCXT 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: 14603964
• MDR Text Key: 293370456
• Report Number: 3009402404-2022-00010
• 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: 06/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UCXTBED
• Device Catalogue Number: UCXTBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• 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; Hospitalization
• Patient Sex: Prefer Not To Disclose