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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 Break (1069); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom technician stating the side rail end tube was broken, rivet was missing from the right side.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 hill-rom technician found the end tube rivet missing on the right side not allowing it to latch.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2010-2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the ratchet rivets to resolve the issue.Based on this information, 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 Key4548206
MDR Text Key5519180
Report Number3006697241-2015-00076
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2015
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 Number8005
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received02/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2009
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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