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  Injury  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

On 12 october 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.

Manufacturer Narrative

Collecting of the information is ongoing additional information will be provide upon investigation conclusion.

Manufacturer Narrative

Arjo received from customer¿s legal counsel medwatch report registered under 365663-2021-0001 which informs about an event where the sara 3000 device was involved.It was reported that during patient transfer when the patient was raised the lift malfunctioned leading to patient fall.As a consequence of the fall the patient hit his head on a dresser and sustained fracture to the patient's 6th vertebra.It was reported that the patient passed away in the hospital.The customer did not provide information what kind of malfunction occurred.Despite attempts to contact the customer and request for additional information, arjo did not receive this information, nor was the lift available for arjo inspection.The ifu for sara 3000 (kkx81919.Ee) contains information: ¿caution: if in doubt about correct operation of the sara 3000, do not use it and contact the arjo service department.¿ to sum up, the sara 3000 floor lift was used with a patient at the time of the event and therefore it is considered as playing a role in the reported event.However, the cause of the patient¿s fall has not been established, since the device could not be evaluated by arjo representative.The customer allegation could not be verified.Due to limited information gathered, it is unknown whether the device met its manufacturer specifications.The complaint was decided to be reportable to the competent authorities due to the allegation that patient fell out from the device during the transfer and passed away.

• 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
• Manufacturer (Section G): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel BE-39 30; BE BE-3930
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12688550
• MDR Text Key: 283405800
• Report Number: 3007420694-2021-00140
• 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: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2021

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2021
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 100 YR
• Patient Sex: Male