MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESENCE LIFT; ELECTRIC PT LIFT

Model Number HOY-PRESENCEWSC

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user the pt slipped out of the lift.The pt was injured and taken to the hosp for medical attention.The resident sustained a bump on the head and was returned to the facility.The facility administrator refused to answer any add'l questions due to hipaa.

Manufacturer Narrative

Joerns sending the report to the mfr.

• Brand Name: HOYER PRESENCE LIFT
• Type of Device: ELECTRIC PT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung, chi yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4734282
• MDR Text Key: 5826719
• Report Number: 3009402404-2015-00010
• 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: 04/21/2015

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: HOY-PRESENCEWSC
• Device Catalogue Number: HOY-PRESENCEWSC
• 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: 04/21/2015
• Distributor Facility Aware Date: 03/30/2015
• Device Age: 1 YR
• Date Report to Manufacturer: 04/21/2015
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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