MAXI SKY 600 LD10203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for MAXI SKY 600 LD10203 manufactured by Arjohuntleigh Magog Inc..

Event Text Entries

[188483751] It was reported to an arjo representative that there was an incident with the involvement of maxi sky 600 ceiling lift and passive clip sling. It was stated that at the middle phase of patient's transfer, from a wheelchair to a bed, left leg sling clip detached from the lift spreader bar attachment point. Following information provided, it seems likely that the clip was not correctly attached to spreader bar before transfer begun. As the consequence of the event the resident fell off the sling and sustained fracture to the arm (just above the left shoulder), fracture above the left elbow, fracture to the right finger and slight concussion. Pain during breathing was also reported. The patient was immediately transferred to the hospital where pain medication was provided. On 2020-feb-20 customer's follow-up visit at the hospital was planned. However, the results of that visit remain unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1419652-2020-00012
MDR Report Key9738425
Date Received2020-02-21
Date of Report2020-02-21
Date of Event2020-02-12
Date Facility Aware2020-02-13
Report Date2020-02-21
Date Reported to FDA2020-02-21
Date Reported to Mfgr2020-02-21
Date Added to Maude2020-02-21
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAXI SKY 600
Generic NameLIFT, PATIENT, NON-AC-POWERED
Product CodeFSA
Date Received2020-02-21
Model NumberLD10203
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age9 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH MAGOG INC.
Manufacturer Address2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-02-21

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