MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. HOYER 600; FSA

Model Number 9600101.06

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Contusion (1787); Fall (1848); Bone Fracture(s) (1870)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 09/30/2016 arjohuntleigh has received fda report ((b)(4)) from (b)(4), the us importer of the device.As per the mdr provided, it was reported by (b)(4) to arjohuntleigh (b)(4) that: "it was reported to the manufacturer by the end user, per the end user, the scale roll pin was stated to walked out, broke, and over time unthreaded with a patient being dropped to the floor last weekend.Patient was being transferred from the bed to a portable commode.After the incident, the facility looked into the area that broke and the threads were broken.The patient was transported to (b)(6) and sustained a knot to the back of the head, broken left little toe and contusion to the left leg.Complaint (b)(4) were entered into our system to have the lift returned to (b)(4) for investigation.As of this writing, the lift has not been returned.".

Manufacturer Narrative

This report is being filled by the manufacturer arjohuntleigh magog inc.(registration #9681684).An investigation was carried out into this complaint.After review of the reportable complaints for hoyer 600 brand name registered within last 5 years, a limited number of similar events where the spreader bar detached from the jib were found.No complaint trend exists for this failure mode.If compared to the number of sold devices and in comparison to their daily use the number of reportable complaints with this failure mode is considered to be low.It was reported to the manufacturer by the end user that the scale roll pin in the lift was stated to strip, broke, and over time unthreaded with a patient (resident) being dropped to the floor.The provided information suggests that the hoyer 600 lift was involved with reportable incident - resident fall to floor as a consequence of spreader bar detachment.The patient was being transferred from the bed to a portable commode.After the incident, the facility looked into the area that was damaged and it was found that threads were broken.The patient sustained a knot to the back of the head, broken left little toe and contusion to the left leg.Please note that the severity of the sustained injuries was assessed by qualified clinical expert - according to the provided opinion they do not meet the definition of serious injury.As per the investigation results and evaluation, it was discovered that the kingpin has backed out from the scale assembly allowing the cradle to disconnect from the lift, damaging the threads of both the kingpin and the scale in the process.Further investigation determined that the roll pin that is meant to prevent the kingpin from backing out has sheared and portions of it remain in both the scale and the kingpin.It is not clear at this time what caused the roll pin to shear.It was noted that the kingpin was bound in the cradle bushing and did not allow moving freely.It is unclear how much force is required to move the kingpin since attempts to move it started to damage the bushings surrounding it, and were subsequently abandoned.No further testing has been performed on the unit since the conditions of the threads in both the scale and kingpin made it unsafe to perform load testing.It is unclear at this time what the cause of the failure to the unit is.Any further testing might be destructive to the current state of the unit.From the analysis performed by the importer, it was not possible to point out the exact root cause of the malfunction with certainty.From the review of the previous complaints on hoyer 600 related to the issue of the spreader bar detachment and our evaluation based on product's labeling, we find the likely causes of these failures can be related to: user error - not performing regular maintenance of the device, unauthorized modification of the device, different anomalies from the manufacturing process, utilization where the caregiver would have pulled on the spreader bar when a patient is supported by the lift causing premature wear of the device.The instruction for use which was delivered with the device (installation and instruction manual-459005 rev.B for hoyer) advises the way of checking the device before use in order to avoid any risk of harm: "always carry out the daily check lift before using the lift." daily check lift: "the following procedure must be followed before each use: inspect the lift for any damage.If there are any cracks or other damage on the lift, or any parts are missing - do not use it.Contact your local representative to have the lift serviced.Inspect the carry bar for any signs of cracking or damage and that it rotates freely." furthermore, according to maintenance inspection checklist in the ifu: "inspect for missing hardware or broken pieces - initially"."check all hardware and swivel bar supports - initially every 2 months." please note also that the device was in usage for about 12 years.Taking into account the above quotes from the manual, it can be stated that if the recommendation included in the instruction for use were followed - inspection of the device condition before use, it is highly probable that the risk of scale separation from the spreader bar could have been avoided.The device failed to meet its specification, it was used for patient handling and due to the spreader bar detachment contributed to the outcome of the event - resident fall to the floor.

Event Description

Arjohuntleigh (the manufacturer) of the device has become aware of the complaint on 2016-september-30th.It was reported to the manufacturer by the end user, per the end user that the scale roll pin in the lift was stated to strip, broke, and over time unthreaded with a patient (resident) being dropped to the floor.The patient was being transferred from the bed to a portable commode.After the incident, the facility looked into the area that was damaged and it was found that the threads were broken.The patient sustained a knot to the back of the head, broken left little toe and contusion to the left leg.The device was returned to (b)(4) for investigation.An investigation report was received from (b)(4) by arjohuntleigh on 2016-december-05th.Pleas note that initially it was reported to food and drug administration that a serious injury occured as an outcome of the event.The clincial expert's opinion revealed that no serious injury occured in fact.

• Brand Name: HOYER 600
• Type of Device: FSA
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6039372
• MDR Text Key: 57794245
• Report Number: 9681684-2016-00048
• 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: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/21/2016,09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nursing Assistant
• Device Model Number: 9600101.06
• 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: 12/21/2016
• Distributor Facility Aware Date: 09/13/2016
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/21/2016
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2004
• 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): Hospitalization; Other
• Patient Age: 79 YR
• Patient Weight: 119