MAUDE Adverse Event Report: ARJO MED. AB LTD. OPERA; LIFT, PATIENT, NON-AC-POWERED

Model Number KPA0300

Device Problem Detachment Of Device Component (1104)

Patient Problem Bruise/Contusion (1754)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo med.Ab ltd (under registration #: (b)(4)).As of 06/15/2010, that number was de-activated due to the site no longer being a manufacturer and until 2014 complaints related to these products were handled by (b)(4) hospital equipment ab and any medwatch reports were submitted under registration #: (b)(4) or medibo (medibo medical products nv / (b)(4)) and ah magog (arjohuntleigh magog, inc./ (b)(4)) from 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #: (b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(6) 2018, an arjo representative was informed about an incident related to a opera passive floor lift which occurred in the (b)(6) hospital ((b)(6)).Following the complaint's description, the mast assembly became detached from the lift base and began to fall forward towards the resident.As a consequence of the event the resident suffered the bruising in the nasal area.

Manufacturer Narrative

Collecting the information is ongoing.Additional information will be provided with investigation conclusion.

Manufacturer Narrative

On 06 -jun-2018 arjo received an information regarding the event with the involvement of the arjo opera passive floor lift.It was reported that during walking exercise, the patient began to feel weak.The caregiver assisted a patient and put her down on the floor.Then, decided to use opera passive lift to lift the patient and transfer back to the bed.During the initial phase of transfer -when the caregiver began to raise the patient from the floor, the mast assembly became detached from the base and fell on the resident.As a consequence of the event, the patient sustained a bruising on the chest and nose.The treatment was provided by the ward staff where the patient was receiving care.The injured was not hospitalized, no medical intervention was required.After the event, arjo representative examined the device and confirmed detachment of the device mast.The supporting photograph evidence provided along with the complaint showed that the mast fell because part of the chassis broke (cross member, part number kpx10500.20).The part which broke is the top part of the chassis.The arjo engineering supervisor, assessed that the breakage issue might be a result of material fatigue.Unfortunately, this hypothesis could not be confirmed with certainty without the additional test.The customer sent the faulty part for further examination to the external company.Unfortunately, testing results were not been made available for arjo.If the test results will be shared and give new light into the investigation or root cause, the follow up report with new conclusion will be sent to authorities.The last device maintenance has been performed on march-2018 by 3 part company.The device was not under arjo service contract.Moreover, it needs to be emphasized, the device was in use for over 16 years.Please note, that the opera device became obsolete since dec-2016.When reviewing similar reportable events for last 5 years, we have not found complaints with similar fault description.Looking at the incident scenario it has been established that opera passive floor lift was used by the caregiver and played a passive role in this incident.The mast detached from chassis base and fall on the patient, and from that perspective, the floor lit device was not according to its technical specification at the time of the incident.No adverse event occurred.The complaint decided to be reportable based on the potential for serious injury if the incident would reoccur.

Manufacturer Narrative

The customer shared with arjo representative results of their internal testing (performed by external laboratory).Evaluation included: hardness test, a chemical analysis and a metallographic examination.The defect was assessed as related to a poor solidification process of the aluminium casting during fabrication.To confirm the above test summary, the involved 16 years old device (part-chassis base) was returned to the arjo manufacturer in magog, canada for further inspection.The part was send to external laboratory where visual inspection of the base, microscopic evaluation and a chemical surface analysis was performed.The reported failure has been confirmed and relates to defect occurring during cooling of the aluminium casting.Although the defect has been confirmed, this product expected operational life has been exceeded about 6 years.Despite that, the device was still in use.Product instruction for use states: "the expected operational life of the opera is 10 years, provided that it has been regularly serviced and maintained as recommended in these instructions." reviewing rolling 5 years back post marked surveilance data review showed that this is an isolated incident.

• Brand Name: OPERA
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO MED. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• MDR Report Key: 7640706
• MDR Text Key: 112872431
• Report Number: 3007420694-2018-00128
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KPA0300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2019
• Distributor Facility Aware Date: 06/06/2018
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 114