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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. ADVANTA 2 BED BED, AC-POWERED ADJUSTABLE HOSPITAL

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HILL-ROM, INC. ADVANTA 2 BED BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P1190A
Device Problems Material Disintegration (1177); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2017
Event Type  malfunction  
Event Description
This did not involve a patient or patient care. During preventative maintenance by the clinical engineering dept, technicians noticed a trend in a plastic bushing disintegrating. The hospital has 170 of these beds and since scrutinizing these, nine have been sequestered. Note: not all beds have been inspected- just a small sampling. One bed was repaired before this trend was noted. Technicians were not sure this would be a hazard for patients. The area where failure is occurring would be the knee/foot section of the bed. Due to the failure there is a significant amount of movement (side play) at the knee/foot section. Hill-rom representative came on site to look at the beds and since they do not have any alert/recall regarding these issues and the beds are no longer under warranty, it would be up to the hospital to repair. Technicians suggest reporting this possible/probable defect. Manufacturer response for advanta 2 hill-rom hosptial bed, hill rom advanta 2 (per site reporter): per the technician, hill rom stated there was no recall/alert regarding this issue and the beds are no longer under warranty.
 
Event Description
This did not involve a patient or patient care. During preventative maintenance by the clinical engineering dept, technicians noticed a trend in a plastic bushing disintegrating. The hospital has 170 of these beds and since scrutinizing these, nine have been sequestered. Note: not all beds have been inspected- just a small sampling. One bed was repaired before this trend was noted. Technicians were not sure this would be a hazard for patients. The area where failure is occurring would be the knee/foot section of the bed. Due to the failure there is a significant amount of movement (side play) at the knee/foot section. Hill-rom representative came on site to look at the beds and since they do not have any alert/recall regarding these issues and the beds are no longer under warranty, it would be up to the hospital to repair. Technicians suggest reporting this possible/probable defect. Manufacturer response for advanta 2 hill-rom hospital bed, hill rom advanta 2 (per site reporter). Per the technician, hill rom stated there was no recall/alert regarding this issue and the beds are no longer under warranty.
 
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Brand NameADVANTA 2 BED
Type of DeviceBED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
HILL-ROM, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key6581190
MDR Text Key258301177
Report Number6581190
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP1190A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2017
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/22/2017 Patient Sequence Number: 1
Treatment
NO; NO OTHER THERAPIES
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