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

Model Number UCXTBED

Device Problems Device Maintenance Issue (1379); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, the cna was having trouble disengaging the ultralock (bed locking system) on the bed with her foot.She used her hand to disengage the ultralock and her thumb got caught and broke.The cna was sent to the er for evaluating and has been seen by an orthopedic surgeon.The cna is on restricted duty and has a splint on the broken thumb.(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.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: ULTRACARE 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: 4774937
• MDR Text Key: 5782854
• Report Number: 3009402404-2015-00014
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/11/2015

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: UCXTBED
• Device Catalogue Number: UCXTBED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2015
• Distributor Facility Aware Date: 05/01/2015
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/11/2015
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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