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

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturer's narrative: an investigation was carried out into this complaint.On (b)(6) 2017 arjohuntleigh has been informed that during the transfer from wheelchair to bed, the patient has fallen down and hit the head against the floor.It was indicated that one left shoulder clip became detached.Other three clips remained in the position - the patient was assisted by two caregivers.As a consequence, the patient received a head injury - left post parietal region had a 2.5 cm hematoma on scalp with a minor abrasion on the lateral edge.To cure the injury, the staff used a type of glue to close the wound, no staples or stitches were required.The injury was assessed by arjohuntleigh clinical expert as non-serious.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).The trend observed for reportable complaints with this failure mode is currently considered to be relatively low and slightly decreasing.The exact manufacturing date of the involved sling could not have been confirmed.Basing on the photographic evidence and information gathered, the sling did not reveal any visible signs of damage.Although the involved lift was manufactured in 1998, its condition was assessed as good, not requiring to have any components replaced.A sling clip, once correctly attached and monitored to stay in place is locked in position as the weight of the person in the sling is gradually taken up.It is not likely to come off during on-label use.Based on product knowledge and previously made simulations this allows two possible sequences of event to occur: based on the information received it is clear that the person was lifted from seated position.From simulations, we know that in the situation, when the clip is not attached and under tension with the weight of the person in the sling from the start, a drop will be immediate.If the labelling is followed there can be no issue.However, it appears very likely for caregivers to not have followed the labelling and not having checked that the clips are correctly attached and remain under tension as the weight of the resident was gradually taken up.The user is obliged to monitor the clips becoming under tension when the weight of the patient is gradually being loaded on.When a transfer occurs from the wheelchair to the bed, this means at some point there must be a repositioning from seated to horizontal position, to place the person in the bed correctly.Also this means that the resident must be turned in the correct direction.When (a) the clip was in place and (b) it was locked in position by the weight of the person in the sling (therefore not likely to come off by itself), from previous simulations, we have been able to establish that the most likely way to detach a clip from that situation, is that the caregiver used the strap on top of the clip - which is there to detach the clip after the transfer has ended - to move and turn the spreader bar into position so that the person in the sling was aligned with the bed.In doing so, when pulling the strap hard enough it can be jolted loose from the spreader bar, the resident weight will come on it and it will be very hard to hold.The sling instruction for use (ifu) currently used contains crucial information: "to avoid injury to the resident, pay close attention when lowering or adjusting the spreader bar." "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process." consequently to the above, it appears most likely that the event was caused by use error, based on the customer information, simulations performed previously and the history of incidents.The use in accordance with the ifu recommendations does not allow a properly functioning sling clip to detach.The device labelling indicates the system should be used by trained personnel that are aware of the ifu contents.Arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to correct lifting procedure.This is to be communicated to the customer.Due to the nature of this incident we are reporting this event to competent authorities due to the potential of harm with a high severity.It has been established that arjohuntleigh sling and lift were in use for patient handling at the time of the event and contributed to the reported outcome due to the use error.Based on the above, the device was found to have malfunctioned (not performing up to the specification) when the event took place.We find this complaint to be reportable to the competent authorities.

Event Description

On (b)(6) 2017 arjohuntleigh has been informed about an event which occurred with the involvement of maximove lift and passive clip sling.According to the information received, during the transfer from wheelchair to bed, the patient has fallen down and hit the head against the floor.It was indicated that one left shoulder clip became detached.Other three clips remained in the position.As a consequence, the patient received a head injury - left post parietal region had a 2.5 cm hematoma on scalp with a minor abrasion on the lateral edge.To cure the injury, the staff used a type of glue to close the wound, no staples or stitches were required.The injury was assessed by arjohuntleigh clinical expert as non-serious.

• Brand Name: MAXIMOVE
• 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
• 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, PL-62-052 ; PL PL-62052
• MDR Report Key: 6580778
• MDR Text Key: 75630613
• Report Number: 3007420694-2017-00114
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/21/2017

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
• 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: 05/21/2017
• Distributor Facility Aware Date: 04/28/2017
• Device Age: 18 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/21/2017
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/1998
• 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: 85 YR
• Patient Weight: 55