MAUDE Adverse Event Report: JOERNS HEALTHCARE ULTRACARE XT BED; ELECTRIC PATIENT BED

Model Number UCXTBED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/06/2017

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, "they were using a lift to put the patient in bed and the patient's calf area where the head panel (back section) pivots from the middle section was able to fit into the gap and her calf got stuck resulting in 26 stitches from the skin tear.One person was working with the patient in the lift and the other person was in the bathroom.The lift model is an easyway lift.No serial was obtained from the lift with their having several lifts of the same kind all of which were checked and had no issue.The bed showed no signs of issue and had everything intact.Both the lift and bed are back in service." (b)(4) were entered into our system to have the bed returned to joerns for investigation.As of this writing, the bed has not been returned.

• Brand Name: ULTRACARE XT BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6949000
• MDR Text Key: 89306967
• Report Number: 3009402404-2017-00050
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2017

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: Lay User/Patient
• Device Model Number: UCXTBED
• Device Catalogue Number: UCXTBED
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Weight: 57