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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION PRIME SERIES; STRETCHER, WHEELED
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STRYKER CORPORATION PRIME SERIES; STRETCHER, WHEELED Back to Search Results
Model Number 1115
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2019
Event Type  malfunction  
Event Description
When raising the cart side rails they did not "click" in to place leaving the potential for the side rails to fall and patient to roll out off the cart.Upon review it was noted that there is not clear direction/labeling as to what is the correct sized mattress to place on the cart.Thicker mattresses cause this problem more than the thinner mattress.Staff have a work around, they "just know" to pull harder for certain carts than others until a click is heard.Affects multiple patients; upon review it was noted that there is not clear direction/labeling as to what is the correct sized mattress to place on the cart.Thicker mattresses cause this problem more than the thinner mattress.
 
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Brand Name
PRIME SERIES
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER CORPORATION
6938 elm valley drive
kalamazoo MI 49009
MDR Report Key8615318
MDR Text Key145227161
Report Number8615318
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2019
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 Health Professional
Device Model Number1115
Device Catalogue Number1115-000-030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/14/2019
Event Location Hospital
Date Report to Manufacturer05/16/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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