MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 2; LIFT, PATIENT, NON-AC-POWERED

Model Number MS000-02-00

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848); Pain (1994)

Event Date 09/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

Arjohuntleigh received a customer complaint indicating that during the resident transfer using maxi sky 2 ceiling lift, the spreader bar came loose of the scale and fell.As a consequence of this event, the resident fell on her lap and lower back.The patient fall resulted in the bruised ankle and skin injury on her arm.X-ray was performed.

Manufacturer Narrative

On 12 sep 2017, arjohuntleigh received an information from (b)(6) indicating that during the resident transfer from a bed to a chair using arjohuntleigh maxi sky 2 ceiling lift, the spreader bar came loose and detached from the quick connect attachment of the corporate suspended scale.As a consequence of the event, the resident fell on her lap and lower back.(b)(6) patient sustained skin abrasion and bruising on her ankle.During radiological examination performed with the use of an x-ray no fracture was identified.The spreader bar is attached to the scale with the use of the quick connect mechanism.This connection allows the caregiver to change the spreader bar in a few steps without using any tools.The procedure how to install the spreader bar is described in the device instruction for use #001-15698 (which is delivered with each arjohuntleigh ceiling lift) step by step, including illustrations showing proper installation of the spreader bar.The scale involved in the complaint (part number: 700-19490, serial number (b)(4) was quarantined and made available for arjohuntleigh's evaluation.Upon the receipt of the components (on 20 oct 2017), the quick connect suspended scale has been subjected to the functional test.The investigation results revealed that under specific and random conditions the spreader bar can detach from the scale: before the patient is installed in the sling, just before initiating the transfer, when a spreader bar is in the wrong position, there is a loose connection created when adjusting the height of the spreader bar.The pin of the bottom attachment of the scale attachment just places itself against the latch of the spreader bar upper attachment of the quick connect.The patient is raised and the transfer is initiated.The pin of the bottom attachment of the scale attachment balances against the latch of the spreader bar upper attachment of the quick connect.The pin eventually goes out from the latch, the spreader bar falls, and the latch closes, without any breakage.Based on these results, it was possible to replicate the presented scenario under specific circumstances.This incident initiated a global recall with an internal reference number fsn-mag-2018-the affected quick connect scale part numbers: 700-19490 (from serial number (b)(4) up to serial number (b)(4) and 700-19485 (from serial number (b)(4) up to serial number (b)(4) are supposed to be corrected in the field.The appropriate communication to customers will be distributed.To conclude, the maxi sky 2 ceiling lift equipped with quick connect scale was being used at the time of the event.The spreader bar was disconnected from the device so from that perspective the system was not according to the manufacturer's specifications.We find this complaint to be reportable to the competent authorities due to the potential of fall during transfer.Specific and random circumstances identified upon the manufacturer simulation presented a remote probability of serious adverse health consequences.

Manufacturer Narrative

Because it was reported to arjohuntleigh that the spreader bar was detached from scale, the involved scale was returned to arjohuntleigh on 20 oct 2017.The quick connect suspended scale was tested to determine if the duplication of the failure mode is possible.The scale was tested with the same type of spreader bar involved in the complaint (part number 600-19350).Note, the spreader bar is attached to the scale with using the quick connect mechanism.This connection allows the caregiver to change the spreader bar in a few steps without using any tools.The procedure how to install the spreader bar is described in the instruction for use (which is delivered with each ceiling lift) step by step, additionally the illustrations show an attachment of lift to scale, scale to spreader bar and lift to spreader bar.According to test results performed so far, the functional inspection demonstrates that it was possible to reproduce the reported failure mode with the product returned.Additional information will be provided upon conclusions of the investigation.

• Brand Name: MAXI SKY 2
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6910037
• MDR Text Key: 88246100
• Report Number: 9681684-2017-00077
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Caregivers
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

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: MS000-02-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2018
• Distributor Facility Aware Date: 09/12/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2018
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 12/20/2017; 02/05/2018
• Supplement Dates FDA Received: 01/11/2018; 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FSN-MAG-2018-01
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 85