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

Model Number U770

Device Problem Fracture (1260)

Patient Problem Laceration(s) (1946)

Event Date 05/10/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility, the resident was being lifted by a lift.The residents right leg brushed against the seat pan of the bed.The seat pad had a chip/crack in it.The resident sustained a skin tear, was sent to the emergency room and received stitches on right leg calf.The resident returned to the facility the same day.Complaint# (b)(4) was entered into our system.

Manufacturer Narrative

The facility disposed of the seat pan that was involved in the incident.

• Brand Name: ULTRACARE PATIENT BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; stevens point WI
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 3980831
• MDR Text Key: 4887865
• Report Number: 3009402404-2014-00018
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: U770
• Device Catalogue Number: U770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2014
• Distributor Facility Aware Date: 05/10/2014
• Device Age: 10 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/16/2014
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2004
• 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: 59 YR
• Patient Weight: 57