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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 3005S3EX
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Fall (1848)
Event Date 03/06/2017
Event Type  malfunction  
Event Description
It was reported that family members of patients turned off the bed exit alarms on the beds to assist patients in using the restroom.It was further alleged that the patients suffered falls and the staff was not notified about the falls due to the bed exit alarms being turned off.The patients subsequently passed away, although the complainant was not aware if the patients expiring was related to the falls.
 
Manufacturer Narrative
The issue was resolved for the customer by confirming that nothing further was required from stryker at this time.Customer did not record serial number of unit involved in this incident.
 
Event Description
It was reported that family members of patients turned off the bed exit alarms on the beds to assist patients in using the restroom.It was further alleged that the patients suffered falls and the staff was not notified about the falls due to the bed exit alarms being turned off.The patients subsequently passed away, although the complainant was not aware if the patients expiring was related to the falls.
 
Manufacturer Narrative
Supplemental submitted to include udi.Customer did not record serial number of unit involved in this incident.
 
Event Description
It was reported that family members of patients turned off the bed exit alarms on the beds to assist patients in using the restroom.It was further alleged that the patients suffered falls and the staff was not notified about the falls due to the bed exit alarms being turned off.The patients subsequently passed away, although the complainant was not aware if the patients expiring was related to the falls.
 
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Brand Name
S3 EX - 3005
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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6471278
MDR Text Key72442887
Report Number0001831750-2017-00115
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,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3005S3EX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/10/2017
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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