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

Model Number UCXTBED

Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)

Patient Problem Contusion (1787)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

The bed was evaluated by the facilities maintenance staff.They concluded that the bed was pressed against the wallwith the head raised, allowing the assist railed to be pushed under the head section of the bed.When the staff member moved the bed, the rail returned to original position and the head section came down on the staff members lower leg causing the injury.

Event Description

It was reported to the manufacturer by the end user, per the end user raising the patient head of electrical bed when the bed collapsed and fell on left lower leg of staff member.Striking the inner left leg above the ankle causing pain as well as an indentation, but did not break the skin.The patient did not sustain any injuries.The staff member was taken to a clinic for evaluation and returned to work that evening with no limitations.Complaint# (b)(4) was entered into our system.

• Brand Name: ULTRACARE XT BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; 5001 joerns drive; stevens point WI 54481
• Manufacturer (Section G): JOERNS HEALTHCARE; 5001 joerns drive; stevens point WI 54481
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 5374289
• MDR Text Key: 36212207
• Report Number: 3009402404-2016-00003
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2011
• 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 Age: 60 YR