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

Model Number KGA0200

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018 arjohuntleigh received information about an event which occurred with the involvement of arjohuntleigh system: (b)(6) passive floor lift and clip sling.It was reported that during the patient transfer from horizontal to seated position, the right shoulder clip detached from hanger bar.According to arjo representative statement from the incident description form (idf): the clip detachment probably occurred, when the patient's weight was not fully suspended on the lift.As a consequence, the patient sustained a wound on the head.No treatment was required.When reviewing similar reportable events registered during last 5 years with similar fault description (clip detachment), we have found a limited number of cases.No malfunctions regarding lift and sling were reported which could have caused or contributed to the event.Although, it is worth noting that both lift and sling were over 10 years old and their replacement should be considered.Every arjohuntleigh sling and lift is supplied with instructions for use (ifu).The (b)(6) ifu ((b)(4)) indicates the steps of proper lifting process and also points out: -"always check that the sling attachment clips are fully in position before and during lifting cycle, and in tension as the patient's weight is gradually taken up." -"the (b)(6) must only be used in accordance with these operation instructions.Any person using the (b)(6) must first read and understand these operating instructions." -"lift the patient using the handset control, and adjust him/her to a comfortable position for transfer." based on the product knowledge and a simulation, it comes forward that when the labeling is followed and the sling is placed in the correct way and the instructions of using the system is followed, there is no possibility of a patient drop or other adverse event during the transfer of the patient with the sling and lift.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as indicated to be required in the labelling, is locked in position with the weight of the patient.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.Review of similar complaints, reported in the past confirmed that this failure is only possible to occur when the labeling is not followed.To conclude, the system: clip sling and lift was used for patient's care and in that way contributed to the alleged event.No defect has been found within the clip, but since the sling clip detached from the spreader bar, it can be stated that the system did not meet its performance specification.We report this event to competent authorities based on the potential for serious injury if the incident would to recur: clip sling detachment upon the transfer.

Event Description

On (b)(6) 2018 arjohuntleigh received information about an event which occurred with the involvement of arjohuntleigh system: (b)(6) passive floor lift and clip sling.It was reported that during the patient transfer from horizontal to seated positon, the right shoulder clip detached from hanger bar.According to arjo representative statement from the incident description form (idf): the clip detachment probably occurred, when the patient's weight was not fully suspended on the lift.As a consequence, patient sustained a wound on the head.No treatment was required.

• Brand Name: MARISA
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJO MED. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• Manufacturer (Section G): ARJO MED. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 7240510
• MDR Text Key: 99099195
• Report Number: 3007420694-2018-00029
• 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
• Report Date: 02/05/2018

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: KGA0200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2018
• Distributor Facility Aware Date: 01/10/2018
• Device Age: 17 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2001
• 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: 83 YR
• Patient Weight: 48