MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER POWER LIFT W/SCALE; PATIENT LIFTER

Model Number HPL700WSC

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 02/06/2014

Event Type  No Answer Provided  

Event Description

It was reported to the mfr by the facility (b)(6), per the facility the resident was being moved from the bed to a wheelchair.The lift was over the wheelchair when the cradle detached from the boom.The resident fell and landed in the wheelchair.The cradle landed on top of the resident.The resident had some shoulder pain and x-rays were performed at the facility as a precaution.Complaint # (b)(4) has been entered into our system to retrieve the lift for investigation.As of this writing, the lift has not been returned to joerns.

• Brand Name: HOYER POWER LIFT W/SCALE
• Type of Device: PATIENT LIFTER
• Manufacturer (Section D): JOERNS HEALTHCARE; matamoros, tamaulipas
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 3660105
• MDR Text Key: 4286951
• Report Number: 3009402404-2014-00005
• Device Sequence Number: 1
• Product Code: FNG
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HPL700WSC
• Device Catalogue Number: HPL700WSC
• 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: 02/18/2014
• Distributor Facility Aware Date: 02/06/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2014
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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 Age: 40 YR
• Patient Weight: 91