MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. SARA STEDY

Model Number NTB2000

Device Problem Defective Component (2292)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

Arjo (b)(4) has been informed about the event where the patient did fall due to castor brake failing to lock.Caregiver locked the castors in place so that the patient could stand and move off the sara stedy, one foot was on the floor and the other foot was on the foot plate of the sara stedy started to move and the patient lost his balance and fell to the floor.Patient did not hurt himself.Ref# mfr 9681684-2014-00027.

• Brand Name: SARA STEDY
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3799176
• MDR Text Key: 4381936
• Report Number: 1419652-2014-00119
• Device Sequence Number: 1
• Product Code: INM
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014,04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NTB2000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2014
• Distributor Facility Aware Date: 04/10/2014
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other