MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV SARA 3000; LIFT, PATIENT, NON-AC-POWERED

Model Number HEA1002-US

Device Problem Material Integrity Problem (2978)

Patient Problem Vertebral Fracture (4520)

Event Date 09/24/2021

Event Type  Death  

Event Description

On (b)(6) 2021 arjo received voluntary medwatch report send by the customer to fda.It was reported that during patient transfer, sara 3000 had a malfunction which led to the patient fall out from the lift.As a consequence of the event patient's head hit the dresser.Arjo received information that patient passed away.The customer did not provide information what kind of malfunction occurred.

• Brand Name: SARA 3000
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel BE-39 30; BE BE-3930
• MDR Report Key: 12688551
• MDR Text Key: 278103077
• Report Number: 1419652-2021-00039
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HEA1002-US
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2021
• Distributor Facility Aware Date: 10/12/2021
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 100 YR