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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. P500 MRS CONTROL UNIT; BED FLOTATION THERAPY POWERED
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HILL-ROM, INC. P500 MRS CONTROL UNIT; BED FLOTATION THERAPY POWERED Back to Search Results
Model Number 0057
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from the hill-rom technician stating the cpr would not work.The bed was located at the hill-rom service center.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the cpr switch was defective.It is necessary for the p500 to have an effective maintenance program.We recommend that you do annual preventive maintenance.Make sure the cpr feature operates correctly.The technician replaced the cpr switch to resolve the issue.Based on this info, no further action is required.
 
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Brand Name
P500 MRS CONTROL UNIT
Type of Device
BED FLOTATION THERAPY POWERED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
tony werner
1069 state route 46 east
batesville, IN 47006
8129312359
MDR Report Key4539317
MDR Text Key5356175
Report Number1824206-2015-00241
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/21/2015
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 Operator Other
Device Model Number0057
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/21/2015
Initial Date FDA Received02/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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