MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB CENTURY

Model Number T50XRID

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 02/01/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh rep who visited the customer site and inspected the device that during lifting procedure with century's saf-lift, pt fall out and got injured.From the info rec'd it is unk what kind of injury occurred to the pt as a result of this incident.Ref # mfr 9611530-2014-00019.

• Brand Name: CENTURY
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• 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: 3737981
• MDR Text Key: 4275680
• Report Number: 1419652-2014-00076
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014,02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T50XRID
• 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: 03/26/2014
• Distributor Facility Aware Date: 02/28/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization