MAXI SKY 600 LD10000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-13 for MAXI SKY 600 LD10000 manufactured by Arjohuntleigh Magog Inc..

Event Text Entries

[187017758] We are in a process of reviewing information gathered. Additional information will be provided upon investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10


[187017759] It was reported to an arjo representative that there was an incident with the involvement of maxi sky 600 and passive clip sling. It was stated that at the initial phase of patient's transfer, when resident was lifted out of the bed, right leg clip detached from the spreader bar attachment point. Following information provided, the patient was restless and in a state of opposition during the lifting procedure. As the consequence of the event the resident fell off the sling and sustained femur fracture and ecchymosis on the left eyebrow.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681684-2020-00012
MDR Report Key9705313
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-13
Date of Report2020-03-12
Date of Event2020-01-25
Date Mfgr Received2020-02-06
Device Manufacturer Date2006-11-07
Date Added to Maude2020-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKINGA STOLINSKA
Manufacturer StreetKS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer Phone688282467
Manufacturer G1ARJOHUNTLEIGH MAGOG INC.
Manufacturer Street2001 TANGUAY STREET
Manufacturer CityMAGOG J1X5Y5
Manufacturer CountryCA
Manufacturer Postal CodeJ1X5Y5
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 Received2020-02-13
Model NumberLD10000
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH MAGOG INC.
Manufacturer Address2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.