MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. SARA LITE; NON-AC-POWERED PATIENT LIFT

Model Number HOA0008

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during usage of the device with a patient (when the patient weight was fully lifted), one of two lift legs detached suddenly from chassis.The patient was taken off the device securely.No injury occurred.

Manufacturer Narrative

On 2017-oct-13 arjohuntleigh has become aware of an event which occurred with the involvement of sara lite active lift in residenza anni azzurri customer facility located in (b)(6).It was reported that during resident transfer with the use of sara lite active lift, the lift's left leg suddenly detached from the chassis.The resident was taken of the device securely by assisting caregivers.No injury was sustained.An investigation was carried out into this complaint.When reviewing similar reportable events, we have found few cases with similar fault description (the chassis leg was either detached or bent).The sara lite lift was out of the manufacturer's specifications at the time of the reported event.Due to a failure of both welds the connection between the leg tubing separated from the leg bushing, causing the device leg separation from the basis.The device required replacement of the device leg before further use.Based on photographic evidence and analysis performed for this specific failure, it was concluded that the leg separation resulted from an inadequate welding - lack of metal fusion between leg tube and bushing.An in-depth investigation of the welding process at the supplier facility identified the cause of potential weld failure to be dimension variations on the leg tubes from the machining process.The variation can cause the welding to occur on the tube side surface rather than at the joint of both parts (leg tube and bushing).This can make non-conformance welding joints due to lack of fusion.Necessary actions have been already taken in manufacturing to eliminate possibility of deviation reoccurrence.The lift involved in the event had been manufactured before their implementation.Additionally, the device's maintenance and repair manual (001-02714 rev.0) states that an inspection of all weld sites for cracking or separation on lift is needed to be performed every year.Based on the number of occurrences, the install base of sara lite active lifts and the estimated number of units expected to develop the defect, the probability of occurrence of harm was deemed to be very low.This estimation was determined through inspection of a number of legs that were manufactured within the same manufacturing process with zero defects found.To conclude, arjohuntleigh sara lite active lift played a role in the complaint issue as was used for patient's transfer at the time the failure occurred.The resident was taken of the lift securely, no injury occurred.There was a device deficiency found (detachment of the lift's leg) and from that perspective the device did not meet the manufacturer's specification at the time of the event.We report this event to the competent authorities because of the reported failure (leg detachment) and the potential that this failure may cause the device to be unstable.

• Brand Name: SARA LITE
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 7012512
• MDR Text Key: 92609207
• Report Number: 9681684-2017-00088
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

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 Caregivers
• Device Model Number: HOA0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2017
• Distributor Facility Aware Date: 10/13/2017
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/06/2017
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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 Age: 87 YR
• Patient Weight: 52