MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SARA 3000; NONE

Device Problems Defective Component (2292); Dent in Material (2526); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  malfunction  

Event Description

It was reported by the company representative: resident had sling around waist, legs strapped in against knee supports.Raised resident, resident standing up at this point with no issues.Resident was just washed and a new diaper was about to put on resident.At this point staff noticed that lifts arms was starting to lower.Technician confirmed that sara 3000 lowered at normal speed.The handset down function was shorted due to normal use.This caused lift to lower.Caregiver had to hold resident up while a third nurse walked in and pushed the up button on the lift handset in order to keep lift from continue to lower by itself.Once resident was situated on chair, lift would no longer operate the up function.At this time caregiver was injured, possible that caregiver stressed his lower back, went to emergency room and was told to rest.Ref mfr # 3007420694-2014-00061.

• Brand Name: SARA 3000
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul ks piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• 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: 3888129
• MDR Text Key: 4424876
• Report Number: 1419652-2014-00140
• Device Sequence Number: 1
• Product Code: FSA
• 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: 05/29/2014,04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• 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: 05/29/2014
• Distributor Facility Aware Date: 04/30/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 102