MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O MINSTREL; LIFT, PATIENT, NON-AC-POWERED

Model Number HMA0011-UK

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Arjohuntleigh received a customer complaint where it was indicated that at the time of lowering the patient onto a bed, using minstrel floor lift, the device tilted sideways.The lift came into contact with the head and left shoulder of first caregiver and foot of second caregiver.Neither injury or harm was reported.No medical intervention was needed.When reviewing similar reportable events, we have found a limited number of cases that may relate to the issue investigated here: minstrel lift tilted sideways during the resident transfer.We have been able to establish that compared to the amount of sold devices and in comparison to their daily use the occurrence rate of reportable complaints with this failure is relatively low.It is worth noting that all minstrel lifts have been designed, produced and certified to meet the requirements of the iso 10535 stability test.It has been proven that even on a tilting slope, the minstrel does not become unstable.Please be aware that this report concerns minstrel passive floor lift with serial number (b)(4), located in sunbeam house services customer facility.In light of provided information, when the resident was about one inch over the bed, the caregiver maneuvered the resident located in the sling by pulling the sling.It resulted in the lift destabilization in the direction that was pulled because the body of the patient was used as leverage.Our evaluation appears to suggest a use error having occurred, the procedure of transfer describes in instruction for use (ifu) was not followed.As per ifu (mmx15030.En rev.8 supplied with the device) the transfer onto bed should be performed in following way: "putting back [the resident] onto a bed, move the hoist to the desired position over the bed and use the remote control to lower the patient." in the labelling there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgeable of the contents of the labelling and correct lifting procedures.When the ifu would have been followed the event would have been avoided.The post incident re-training will be recommended to the involved caregiver staff.To sum up, the device was being used at the time of the event and played a role due to a use error - causing the device not perform as intended.There was no technical failure of the device.The complaint decided to be reportable in abundance of caution, based on the potential of patient injury if the incident would to recur.

Event Description

Arjohuntleigh received a customer complaint where it was indicated that at the time of lowering the patient onto a bed, using minstrel floor lift, the device tilted sideways.The lift came into contact with the head and left shoulder of first caregiver and foot of second caregiver.Neither injury or harm was reported.No medical intervention was needed.

• Brand Name: MINSTREL
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6759588
• MDR Text Key: 83689694
• Report Number: 3007420694-2017-00166
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: HMA0011-UK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Distributor Facility Aware Date: 07/11/2017
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/02/2017
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2012
• 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: 35 YR