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K-4 D³X SkinGuardMS8Recalls & reported problems

Kap Medical · Alternating Pressure with Low Air Loss Mattress System, 80" x 36" x 8" · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817012021899), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Deflation Problem1

Patient problems

  • Tissue Breakdown1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 24, 2020Deflation Problem

    PER REPORT RECEIVED FROM (B)(6) ON (B)(6) 2020, THE FACILITY DISCOVERED THE MATTRESS SUPPORTING THE PATIENT DEFLATED. THE CONTROL UNIT SHOWED A LOW PRESSURE WARNING AND ALARM. THE NURSE REPORTS THE PATIENT DEVELOPED DEEP TISSUE WOUND ON THE BUTTOCKS AS A RESULT OF THE DEFLATION.

    Patient problems: Tissue Breakdown

    MAUDE report 10891827 ↗

Other Mattress, Air Flotation, Alternating Pressure devices

All Mattress, Air Flotation, Alternating Pressure devices →

Sources and updates

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