MAUDE Adverse Event Report: ARJO MED AB LTD OPERA

Model Number SPA0310

Device Problems Unintended Arm Motion (1033); Component Falling (1105)

Patient Problems Sprain (2083); No Consequences Or Impact To Patient (2199)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

The patient was lifted from the wheelchair and being lowered to the x-ray lab table for an exam when the lift suddenly dropped downward 3-4 inches, touching the table.The lift operator instinctively tried to catch the downward drop and his fifth finger got caught between the patient and the lab table.The patient was lowered to the table and the disposable clip sling was removed.The patient had no injury.The lift operator sprained his finger but no treatment was administered.(b)(4).

• Brand Name: OPERA
• Manufacturer (Section D): ARJO MED AB LTD; st. catherine street; glouceste GL1 2SL; UK GL1 2SL
• Manufacturer (Section G): ARJO MED AB LTD; st. catherine street; gloucester GL1 2SL; UK GL1 2SL
• MDR Report Key: 3771240
• MDR Text Key: 4443281
• Report Number: 1419652-2014-00014
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPA0310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Distributor Facility Aware Date: 12/18/2013
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 68