DeRoyal M2100-SLRecalls & reported problems
Deroyal Industries, Inc. · Bed Alarm Monitor - Latching · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756878708), received between Jan 3, 2019 and Jan 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Audible Alarm” (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 16, 2026.
Most reported problems
Device problems
- No Audible Alarm1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2019No Audible Alarm; No Audible Alarm
QUALITY ISSUE DETAILS. DATE OF OCCURRENCE: (B)(6) 2018. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE, DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: THE ALARM WAS USED FOR A PATIENT AND THE RN REPORTED USING THE NORMAL PROCESS. THE PATIENT SLID TO THE FLOOR AND THE ALARM DID NOT SOUND. WHEN THE ALARM WAS TESTED LATER IT SEEMED TO WORK APPROPRIATELY. THE RN IS CERTAIN THAT THE ALARM HAD BEEN PROPERLY SET AND HAD MALFUNCTIONED. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? USED TO MONITOR PATIENTS AT RISK OF FALLING OUT OF THE CHAIR. WAS IT THE INITIAL USE OF THE PRODUCT? NO. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? YES. PLEASE DESCRIBE CONNECTED EQUIPMENT TYPE, SETTINGS, ETC.: USED WITH OUR CHAIR SENSOR (M2200-CP) HAS THE END USER NOTIFIED THE MANUFACTURER OF THE OTHER DEVICES USED IN
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8212375 ↗
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- Voalte Patient Safety 4.0Hill-Rom, Inc. · MONITOR, BED PATIENT1 recall0 reports
- Cubby Beds KIT10001Sensory Medical, Inc. · Monitor, Bed Patient30 reports
- Medline MDT8450YMedline Industries, Inc. · MONITOR, BED PATIENT29 reports
- POSEY 8309ELPosey Products, LLC · Monitor, Bed Patient2 deaths19 reports
- POSEY 8399Posey Products, LLC · Monitor, Bed Patient19 reports
- POSEY 8645WLPosey Products, LLC · Monitor, Bed Patient17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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