MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB CENTURY

Device Problems Component Falling (1105); Shelf Life Exceeded (1567); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

Initially, it was reported by arjhuntleigh representative that during bathing procedure caregivers sat resident on the tub chari for a bath, when they were attempting to lift chair it completely collapsed.They were able to hold the chair and slowly slide it down to the floor.Resident was removed from chair safety.From the information received sore back occurred to the caregiver as a result of this incident.Reference mfr report #9611530-2014-00015.

• 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: 3723529
• MDR Text Key: 21721743
• Report Number: 1419652-2014-00052
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/25/2014
• Distributor Facility Aware Date: 01/30/2014
• Device Age: 13 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 60