Reported Reactions

Devices › Lift, patient, non-ac-powered

Device brand name · Lift patient non-ac-powered

Maxi Sky 2: medical device reports filed with FDA

151 reports name it, 2015–2026. Manufacturer given most often on reports: Arjohuntleigh Magog. Product code FSA.

151
device reports naming the brand
0% of all MAUDE reports · about 14 a year
21
reports, 12 months to August 2026
24 in the 12 months before
70.9%
classified as malfunction
67.8% across the product code
5.3%
classified as death, as reported
8 reports · not verified by FDA

FDA's MAUDE database holds 151 reports that name the brand "Maxi Sky 2" (lift patient non-ac-powered), received between May 2015 and August 2026; the manufacturer given most often on reports is Arjohuntleigh Magog. Spellings of one product vary from report to report.

21 reports arrived in the 12 months to August 2026, down 12% from 24 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (70.9%), injury (23.8%) and death (5.3%); across all lift, patient, non-ac-powered reports (product code FSA) death is recorded in 2.8% and malfunction in 67.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are detachment of device or device component (46.4%), unintended movement (6.6%) and insufficient device problem information (2.6%). The patient problems coded most often are fall, bone fracture(s) and bruise/contusion. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

036Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 22022Jan 2022: 0Feb 2022: 3Mar 2022: 0Apr 2022: 1May 2022: 2Jun 2022: 0Jul 2022: 0Aug 2022: 2Sep 2022: 0Oct 2022: 1Nov 2022: 0Dec 2022: 12023Jan 2023: 0Feb 2023: 3Mar 2023: 1Apr 2023: 2May 2023: 5Jun 2023: 2Jul 2023: 1Aug 2023: 5Sep 2023: 1Oct 2023: 3Nov 2023: 4Dec 2023: 22024Jan 2024: 2Feb 2024: 0Mar 2024: 4Apr 2024: 1May 2024: 0Jun 2024: 2Jul 2024: 5Aug 2024: 3Sep 2024: 1Oct 2024: 0Nov 2024: 1Dec 2024: 52025Jan 2025: 2Feb 2025: 1Mar 2025: 2Apr 2025: 1May 2025: 3Jun 2025: 1Jul 2025: 6Aug 2025: 1Sep 2025: 4Oct 2025: 3Nov 2025: 0Dec 2025: 12026Jan 2026: 2Feb 2026: 1Mar 2026: 2Apr 2026: 2May 2026: 1Jun 2026: 0Jul 2026: 1Aug 2026: 4

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

015292015: 320152016: 52017: 820172018: 72019: 420192020: 122021: 1120212022: 102023: 2920232024: 242025: 2520252026: 13

Event type and report source

Event type, as classified on the report

Death5.3%8
Injury23.8%36
Malfunction70.9%107
Other0%0
Not given0%0

Who filed the report

Manufacturer report89.4%135
Voluntary report0%0
User facility report0%0
Distributor report9.9%15
Not given0.7%1

Grey bar: all 15,182 reports carrying product code FSA. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Detachment of device or device componentpart of the device came off7046.4%6.6%
Unintended movement106.6%2.6%
Insufficient device problem information42.6%2.3%
Device fell21.3%1.1%
Off-label use21.3%0%
Unclear information21.3%0.1%
Device dislodged or dislocated10.7%0.3%
Device tipped over10.7%4.7%
Material rupture10.7%0.3%
Tear, rip or hole in device packaging10.7%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Falla fall117.3%
Bone fracture(s)85.3%
Bruise/contusion53.3%
Hematomaa collection of blood under the skin or in tissue53.3%
Laceration(s)53.3%
Abrasion21.3%
Head injurya head injury21.3%
Painpain, site not specified21.3%
Tissue breakdown21.3%
Concussionconcussion10.7%
Damage to ligament(s)10.7%
Headachehead pain10.7%
No patient involvement10.7%
Nodule10.7%
Skin tears10.7%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMaxi Sky 2Product code FSAAll MAUDE reports
Reports15115,18226,136,888
Share of that pool—1%0%
Classified as death, per 1,000 reports53289
Classified as injury23.8%18.8%36.2%
Classified as malfunction70.9%67.8%62.3%
Filed by the manufacturer89.4%87.4%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code FSA

BrandReportsLatest 12 monthsClassified as death
Non Ac-Powered Patient Lift2,66800.3%
Maxi Move785263.6%
Alenti27795.4%
Sara 300027884%
Power Lift W/Low Base-Plus 915363351923902.1%
Hydraulic Lift W/Adj Base Beige Powdercoat 915364467921400.5%
Maxilift22602.2%
Maxi Twin192176.3%
Hydraulic Lift W/Adj Base 915362936018200%
Hoyer Lift26002.7%
Marisa18604.8%
Hydraulic Lift W/Low Base-Plus 915363352116100%
Maxi Sky 60018872.7%
Golvo15904.4%
Viking18115%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Maxi Sky 2 reports

How many FDA reports name Maxi Sky 2?

151 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 21 in the latest 12 months.

What kinds of events are reported?

malfunction (70.9%), injury (23.8%) and death (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

detachment of device or device component (46.4%), unintended movement (6.6%), insufficient device problem information (2.6%), device fell (1.3%) and off-label use (1.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (89.4%) and distributor reports (9.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Maxi Sky 2 was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.