Envella™ Bed P0819ARecalls & reported problems
Hill-Rom, Inc. · Hospital Bed · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Hill-Rom Envella is an air fluidized hospital bed. Its 330 reports describe material that splits, cuts or tears, unintended bed movement, and activation problems, and some describe a power cord that caught fire and brake casters that did not hold. The reports include no deaths and 12 injuries. No recalls name this device. Reports fell to 73 in the last 12 months from 146 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 331
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 00887761013834), received between Apr 11, 2019 and Sep 29, 2026 — classified as 12 injuries, 319 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (149 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn149
- Unintended Movement57
- Activation Problem49
- Sparking18
- Flare or Flash15
- Electrical Power Problem6
- Material Frayed6
- No Audible Alarm6
Patient problems
- No Clinical Signs, Symptoms or Conditions315
- Pressure Sore/Ulcer8
- No Patient Involvement3
- Unspecified Tissue Injury2
- Fall1
- Foreign Body Sensation in Eye1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 331 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937358 ↗MalfunctionSep 28, 2026Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926339 ↗MalfunctionSep 24, 2026Flare or Flash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886015 ↗MalfunctionAug 11, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216759 ↗MalfunctionAug 7, 2026Flare or Flash
Baxter received a report that ENVELLA BED had power cord and wall outlet caught on fire. This occurred during patient use. There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184050 ↗MalfunctionAug 7, 2026Material Split, Cut or Torn
Baxter received a report stating that ENVELLA BED brake casters were not holding. This occurred during patient use. There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182077 ↗MalfunctionJun 29, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660529 ↗MalfunctionJun 26, 2026Material Split, Cut or Torn
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED POWER CORD WAS DAMAGED AND COPPER WIRE EXPOSED. USER DEFINED DESCRIPTION: WAREHOUSE REPAIR. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25632772 ↗MalfunctionJun 26, 2026Unintended Movement
DURING SERVICING BY BAXTER, TECHNICAL SERVICE IDENTIFIED THAT ENVELLA BED BREAKS WERE NOT HOLDING. USER DEFINED DESCRIPTION:WAREHOUSE REPAIR. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25632634 ↗MalfunctionJun 17, 2026Activation Problem
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD CPR FUNCTION NOT WORKING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25539299 ↗MalfunctionJun 10, 2026No Audible Alarm; Use of Device Problem
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD BED EXIT ALARM NOT WORKING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460978 ↗MalfunctionMay 29, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336745 ↗MalfunctionMay 25, 2026Flare or Flash
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD POWER CORD BURNT FROM INLET. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273240 ↗MalfunctionMay 22, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260868 ↗MalfunctionMay 14, 2026Material Split, Cut or Torn
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED HAD POWER PLUG BURNT. USER DEFINED DESCRIPTION:WAREHOUSE REPAIR. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179250 ↗MalfunctionMay 14, 2026Flare or Flash
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD BURNT AT OUTLET. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177644 ↗MalfunctionMay 13, 2026Unintended Movement
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD BRAKES NOT HOLDING WHILE IN BRAKE. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164041 ↗MalfunctionMay 7, 2026Unintended Movement
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED BRAKES WERE NOT HOLDING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. IT WAS UNKNOWN IF ANY SECOND DEVICE WAS ALSO INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108373 ↗MalfunctionMay 5, 2026Unintended Movement
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD BRAKES NOT HOLDING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088503 ↗MalfunctionApr 27, 2026Material Split, Cut or Torn
A OTHER HEALTH CARE PROFESSIONAL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED HAD POWER CORD EXPOSED COPPER. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25007157 ↗MalfunctionApr 14, 2026Material Split, Cut or Torn
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED HAD POWER CORD DAMAGED AND COPPER WIRE WERE EXPOSED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877571 ↗MalfunctionApr 6, 2026Material Split, Cut or Torn
A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED HAD AN ISSUE, POWER CORD DAMAGED AND COPPER WIRE WAS EXPOSED. USER DEFINED DESCRIPTION:WAREHOUSE REPAIR. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24795658 ↗MalfunctionApr 2, 2026Activation Problem
BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD CPR NOT WORKING ON EITHER SIDE OF BED. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772270 ↗MalfunctionMar 20, 2026Unintended Movement
ON (B)(6) 2026, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT ENVELLA BED (PRODUCT CODE P0819A, SERIAL NUMBER (B)(6), HAD BRAKES NOT HOLDING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654546 ↗MalfunctionMar 18, 2026Material Split, Cut or Torn
BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629869 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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