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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 5700000000
Device Problem Device Alarm System (1012)
Patient Problems Wound Dehiscence (1154); Fall (1848)
Event Date 09/01/2016
Event Type  malfunction  
Event Description
It was reported that the patient fell from the bed, but the bed exit did not alarm to alert the staff.It was alleged that the patient re-opened a previous knee injury during the fall, but that it only required a bandage.No further medical intervention or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
A visual and functional inspection was performed by the user facility.The account stated that the patient was known to kick and move around in the bed frequently, and he may have kicked the footboard out of place and caused it to lose connection with the bed, thus preventing the bed exit from alarming.The issue was resolved for the customer by confirming that nothing further was required by the account at this time.
 
Event Description
It was reported that the patient fell from the bed, but the bed exit did not alarm to alert the staff.It was alleged that the patient re-opened a previous knee injury during the fall, but that it only required a bandage.No further medical intervention or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental submitted to include udi.
 
Event Description
It was reported that the patient fell from the bed, but the bed exit did not alarm to alert the staff.It was alleged that the patient re-opened a previous knee injury during the fall, but that it only required a bandage.No further medical intervention or clinically relevant delay in treatment was reported.
 
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Brand Name
SPIRIT SELECT
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
portage MI N6E 1 R6
CA  N6E 1R6
Manufacturer (Section G)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
portage MI N6E 1 R6
CA   N6E 1R6
Manufacturer Contact
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6038451
MDR Text Key57866956
Report Number0001831750-2016-00323
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5700000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/21/2016
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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