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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVISION BLOWER KIT; BED, FLOTATION THERAPY, POWERED
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HILL-ROM BATESVILLE ENVISION BLOWER KIT; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P136026
Device Problem Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2023
Event Type  malfunction  
Event Description
Hillrom received a report from a hillrom technician stating the bed had cpr feature inoperative.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).
 
Manufacturer Narrative
The hillrom technician found the cpr button switch needed to be replaced.Per the hillrom service manual make sure cpr for proper operation.Repair or replace the part as applicable.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on february 09, 2023.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the cpr button switch to resolve the reported event.B ased on this information, no further action is required.
 
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Brand Name
ENVISION BLOWER KIT
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
maritza valencia
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key17407190
MDR Text Key320732027
Report Number1824206-2023-00825
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2023
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
Device Model NumberP136026
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/19/2023
Initial Date FDA Received07/27/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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