MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SARA PLUS

Model Number HEP1001 US

Device Problems Failure To Service (1563); Inadequate or Insufficient Training (1643); Use of Device Problem (1670)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has become aware of the customer complaint indicating that during the resident transfer, using the sara plus standing aid, the device castor brakes failed causing the device to move unintentionally.The involved caregiver instead of pushing the red emergency stop button and using the system failure lowering override to put the patient back into a safe position, decided to complete the transfer and move the patient manually.As a consequence of this event, the caregiver suffered a back pain.No further information concerning the reported injury had been revealed by the customer facility.No injury or consequence to patient was reported.

Manufacturer Narrative

An investigation was performed based on the gathered complaint information.When reviewing similar reportable events registered since 2011 for sara plus and similar devices, we have found a numbers of complaints where different forms of misuse occurred.However looking at the circumstances and sequence of the events reported under this particular complaint, the issue voiced by the customer in this case appears to be an isolated occurrence.The sara plus is a standing and raising aid designed for hospitals, nursing homes or other health care facilities for the different categories of residents/patients.To provide an easy and safe usage of the devices, it is crucial to follow all safety instructions included in the device instruction for use.In case of electrical or functional failure, the emergency stop button shall be activated to cut all electronics function and provide a safe way of getting the patient down by using the lower override knob feature.In this case, the caregiver instead of activating the emergency stop and using the emergency lowering feature, removed the patient (who was safe situated in the sling) manually.It need to be emphasized that the hoist was put through a function and visual test by the arjohuntleigh representative that visited the customer site.The device was found to be in a full working order.The stated failure could not be reproduced.The sara plus device was tested and found to work to the manufacturer specification.No technical malfunction was found and the device was returned to the customer.From these findings, the device played a role in the reportable event while it was being used with a patient - not due to a malfunction as was suggested but due to the customer / user not following the instructions for use which put the patient in the risky situation.If the ifu and the correct transferring procedure would have been followed with using adequate precautions, the event would have been avoided.This is to be communicated to the customer.We find this complaint to be reportable to the competent authorities in abundance of caution - since we see from customer indications and our investigations that there was a manual release from the device by an operator that does not appear to have had knowledge of how to correctly use the device, which opens the door to the potential for patient harm.

• Brand Name: SARA PLUS
• Type of Device: SARA PLUS
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. piotra wawrzynika 2; komorniki, 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. piotra wawrzynika 2; komorniki, 62052 ; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5821627
• MDR Text Key: 50391128
• Report Number: 3007420694-2016-00154
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/26/2016,06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEP1001 US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2016
• Distributor Facility Aware Date: 06/28/2016
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2016
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2015
• 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
• Patient Weight: 163