MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O. O. SARA 3000; LIFT, PATIENT, NON-AC-POWERED

Model Number HEA0002-US

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On 2017-feb-10 arjohuntleigh received complaint for sara 3000 active floor lift, where it was stated that when the resident was either standing or was in the process of standing up, the foot plate slipped off and resident fell forward.The resident's face/chin hit in the device's pillow.No injury reported.

Manufacturer Narrative

An investigation was performed based on the received complaint.Arjohuntleigh has become aware of a customer complaint alleging that at the time of lifting the resident using arjohuntleigh sara 3000 standing hoist, the plastic foot plate support cover detached and slid down from its base.As a consequence of that, the resident's face/chin hit the device.Fortunately, no medical intervention was required.Any injury or harm occurred.After the incident, the lift was repaired by a 3rd party service and despite our attempts made to clarify the alleged event, any additional information have been disclosed.In respect to this information, this may be a sign that we may end up with some questions unanswered.When reviewing similar reportable events registered during last 5 years (jan 2012 up to mar 2017), we have a very limited number of previous events that may relate to the investigated component: foot support plate.We have been able to establish that compared to the amount of sold devices and in comparison to their daily use the occurrence rate observed for reportable complaints with this failure is relatively low.Based on our product knowledge and detailed evaluation of this nature of complaints the failure is possible to occur once the wheelchair's footplate overlapped the base of our equipment.Because of this, the foot support might be loosened and slipped down from the device base.Due to limited information, we cannot assess with a height degree of certainty whether this was a contributing factor here.It is worth noting that the foot plate stability depends on the distribution of forces put on it by the weight, movement and angle of the feet and knees of the resident being lifted.Even if the foot plate is detached from the device, while the person's knee presses the knee support but the sling is correctly attached to the person and the device as per labelling, there is no risk for patient injury.Please also note that sara 3000 device includes maintaining instructions in order to maintain the proper working condition of the device.As the device not under arjohuntleigh service, it remains unknown whether maintenance was performed within recommended periods.In summary, the device was being used at the time of the event and played a role in the reported incident.The device footsupport was found to be disconnected from the chassis base.From that perspective, it appears the device was not up to specification at the time of the incident.We find this complaint to be reportable to the competent authorities in abundance of caution, due to the potential of serious injury if the incident would to recur - the patient's fall.

• Brand Name: SARA 3000
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6390702
• MDR Text Key: 69441855
• Report Number: 3007420694-2017-00054
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HEA0002-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2017
• Distributor Facility Aware Date: 02/10/2017
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/10/2017
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2012
• 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): Other