MAUDE Adverse Event Report: ARJO HOSP EQUIPMENT AB SYSTEM 2000

Model Number AD33312US1011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/27/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh rep that after bathing the resident, staff member got her foot caught on shower hose that was lying on the floor, tripped and fell against the wall.From the info received caregiver fractured his wrist as a result of this incident.Ref mfr number 9611530-2014-00022.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSP EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• MDR Report Key: 3738073
• MDR Text Key: 4311784
• Report Number: 1419652-2014-00081
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014,03/03/2014

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: AD33312US1011
• Was Device Available for Evaluation?: Yes
• 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: 03/03/2014
• Device Age: 1 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 59