MAUDE Adverse Event Report: INTEGRATED MEASUREMENT SYSTEMS HOYER POWER LIFT; ELECTRIC PATIENT LIFT

Model Number HPL402

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 10/20/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility the cradle disconnected from the lift and the resident fell to the floor.The facility states that the retainer bolt and nut were missing from the king pin on the cradle.The resident was taken to the hospital for evaluation of the left leg and headache.The resident sustained a bruise due to the incident and was returned to the facility the same day.(b)(4) were entered into our system to retrieve the lift for investigation at joerns.As of this writing, the lift has not been returned to joerns.

• Brand Name: HOYER POWER LIFT
• Type of Device: ELECTRIC PATIENT LIFT
• Manufacturer (Section D): INTEGRATED MEASUREMENT SYSTEMS; elk grove village IL
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014-0000 ; 8008260270
• MDR Report Key: 4257433
• MDR Text Key: 18033745
• Report Number: 3009402404-2014-00022
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HPL402
• Device Catalogue Number: HPL402
• 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: 11/03/2014
• Distributor Facility Aware Date: 10/20/2014
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/03/2014
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2002
• 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: 78 YR
• Patient Weight: 108