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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number UNK_MED
Device Problem Device Alarm System (1012)
Patient Problems Death (1802); Fall (1848); Head Injury (1879)
Event Date 11/25/2017
Event Type  Death  
Event Description
It was reported that the patient fell out of bed twice and allegedly the bed exit did not alarm.It was further alleged that the patient hit their head during the fall, leading to possible internal hemorrhaging and subsequent death.
 
Manufacturer Narrative
Upon evaluation no defects were found the unit.
 
Event Description
It was reported that the patient fell out of bed twice and allegedly the bed exit did not alarm.It was further alleged that the patient hit their head during the fall, leading to possible internal hemorrhaging and subsequent death.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
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
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7139122
MDR Text Key95525659
Report Number0001831750-2017-00594
Device Sequence Number1
Product Code FNL
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,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2003
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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