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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO IT AMBULANCE - OBS; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER PRO IT AMBULANCE - OBS; STRETCHER, WHEELED Back to Search Results
Catalog Number 6510000000
Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Device Tipped Over (2589)
Patient Problems Fall (1848); Injury (2348)
Event Date 05/13/2014
Event Type  Injury  
Event Description
It was reported that the safety bar missed the safety hook and the cot tipped.The customer reported that the cot tipped over and fell with an infant while the ambulance crew was removing the cot from the ambulance.The customer reported that the infant was injured in the fall.The customer reported that they believe that the ambulance crew removed the cot incorrectly and missed the safety hook.The unit was evaluated by a service technician with no failure detected.
 
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Brand Name
POWER PRO IT AMBULANCE - OBS
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
anthony noora
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3851157
MDR Text Key4680426
Report Number0001831750-2014-03039
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 05/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number6510000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/13/2014
Initial Date FDA Received06/05/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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