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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TotalCare Bed; BED, AC-POWERED ADJUSTABLE HOSPITAL

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BAXTER HEALTHCARE CORPORATION TotalCare Bed; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P1900Q
Medical Device Problem Code Positioning Failure (1158)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/18/2026
Type of Reportable Event Malfunction
Event or Problem Description
Baxter received a report that totalcare the head of the bed will not rise up.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
 
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
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Brand Name
TotalCare Bed
Common Device Name
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
+1(224)270-5355
MDR Report Key50737205
Report Number1824206-2026-02195
Device Sequence Number18807131
Product Code FNL
UDI-Device Identifier00887761000858
UDI-Public(01)00887761000858
Combination Product (Y/N)N
Initial Reporter StateNA
Initial Reporter CountryJA
PMA/510(K) Number
K962942
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,Company Representative
Type of Report Initial
Report Date (Section B) 09/11/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberP1900Q
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/18/2026
Initial Report FDA Received Date09/11/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
N/A.
Patient SexUnknown
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