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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT PLATFORM; BED, MANUAL
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STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT PLATFORM; BED, MANUAL Back to Search Results
Catalog Number 5800000000
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Injury (2348)
Event Date 02/08/2012
Event Type  Injury  
Event Description
It was reported that the patient slid off the edge of the bed on the mattress and hit his head.There is no additional information regarding the severity of the alleged injury.
 
Manufacturer Narrative
The customer did not allege a malfunction with the unit and was therefore not evaluated.(b)(4) was acquired by stryker on jan.2, 2015.  this medwatch is being submitted late because it was identified during the  integration and remediation activities initiated by stryker medical in conjunction with this acquisition.   no malfunction was alleged by the user facility.
 
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Brand Name
SPIRIT PLATFORM
Type of Device
BED, MANUAL
Manufacturer (Section D)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
N6E 1R6
CA  N6E 1R6
Manufacturer (Section G)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
N6E 1R6
CA   N6E 1R6
Manufacturer Contact
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key4879378
MDR Text Key5867274
Report Number3006433555-2015-00310
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 Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/08/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number5800000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/08/2012
Was Device Evaluated by Manufacturer? No
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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