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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILLROM DE MEXICO S DE RL DE CV STANDARD STRETCHER; WHEELED STRETCHER
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HILLROM DE MEXICO S DE RL DE CV STANDARD STRETCHER; WHEELED STRETCHER Back to Search Results
Model Number 8005
Device Problems Component Missing (2306); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2014
Event Type  malfunction  
Event Description
Hill-rom technical support received a report from the account stating the cap nut on the side rail post is missing (siderail) not latching.The bed was located at the account.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The hill-rom tech support found the siderail not latching due to the cap nut missing.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.Hill technical support provided the part number to order and the account will replace to resolve the issue.Based on the info, no further action is required.
 
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Brand Name
STANDARD STRETCHER
Type of Device
WHEELED STRETCHER
Manufacturer (Section D)
HILLROM DE MEXICO S DE RL DE CV
apodaca
MX 
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key3958507
MDR Text Key20325648
Report Number3006697241-2014-00510
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2014
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 Number8005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/19/2014
Initial Date FDA Received06/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2011
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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