DRIVE

Report

• Report Number: 2438477-2020-00016
• Date Received: February 26, 2020
• Date of Event: December 2, 2019
• Report Date: February 26, 2020
• Manufacturer: APEX HEALTH CARE MFG., INC.
• Product Code: FSA
• UDI-DI: 00822383117898
• Report Source: Distributor report
• Reporter Location: US
• Reporter Occupation: 501

Narratives

Description of Event or Problem · 1

DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A S PATIENT LIFT. THIS REPORT IS IN RESPONSE TO MW5091616. WE ARE CORRECTING INACCURATE DATA IN THE REPORT. PATIENT WAS IN A LIFT SLING WHEN THEY MOVED TO THE RIGHT AND FELL. HE WAS LETHARGIC. HE WAS TAKEN TO THE EMERGENCY ROOM FOR TESTS THAT WERE NEGATIVE. NO INJURY AS A RESULT OF THE FALL. THE LIFT IS 6 YEARS OLD. THERE IS NO DEFICIENCY IN THE LIFT OR THE SLING. THE MW REPORT NOTES SERIOUS INJURY WHICH IS INACCURATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
220037	DRIVE	BARIATRIC PATIENT LIFT	FSA	APEX HEALTH CARE MFG., INC.	12345		00822383117898

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• Fall

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission