MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SARA 3000

Model Number HEA0002-US

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.Arjohuntleigh will be trying to obtain additional information relating the new fact revealed by the facility.We will provide a follow up report based on details we will receive.

Event Description

Arjohuntleigh has became aware of the customer complaint indicating that during the resident transfer from sara 3000 standing aid to miranti hygenic chair, the resident had suffered an arm injury.Based on information available so far, during the reported incident the resident had hand caught in alenti chair and wrist fracture occurred.

Manufacturer Narrative

(b)(4).On 2016-07-04 arjohuntleigh received a complaint stating that a patient sustained a fractured wrist while using a sara 3000 lift to transfer the resident onto the tub lift - alenti.No further details regarding the event has been disclosed to arjohuntleigh.During the case review with (b)(6)- the p&pac equipment consultant - it turned out that the event may have taken place due to the fact that the resident's arm got caught between the alenti post and the handle on the sara 3000.So when the patient was lowered into the alenti and was hanging onto the outside hand grips, the pressure from the residents arm was caught against the pillar of the alenti what caused the break.The patient has been sent to (b)(6) hospital where the cast was applied.No other injuries were reported to arjohuntleigh.The device was inspected and there were no deviations found.Sara 3000 was working according to the specifications.It can be concluded that the caregiver was not adequately trained to the provided instruction how to transfer the patient from sara 3000 to another device.Instructions for use describe this activity and contain warning towards taking care not to lower the resident support arms onto the resident or any obstructions.In summary, the exact user error found here and on this device are a rarely occurring issue.The event described in the complaint is not regarded a technical device malfunction but a user error due to inadequate/insufficient training.The device was being used for patient handling, was up to specification and appears to have been involved only as a result of the described use error.The complaint will be reportable due to the sustained injuries - wrist fracture.

• Brand Name: SARA 3000
• Type of Device: SARA 3000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5836482
• MDR Text Key: 50838225
• Report Number: 3007420694-2016-00161
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/30/2016,07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: HEA0002-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: 08/01/2016
• Distributor Facility Aware Date: 07/04/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/30/2016
• Date Manufacturer Received: 09/21/2016
• 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