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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
No malfunction of the device is alleged.
 
Event Description
It was reported that a patient used the restraints and the restraint strap bracket as a ligature in an attempt to self-harm.However, it was confirmed that there was no serious injury or harm to the patient as a result of the alleged event.
 
Manufacturer Narrative
Device evaluated by manufacturer? no malfunction of the device is alleged.
 
Event Description
It was reported that a patient used the restraints and the restraint strap bracket as a ligature in an attempt to self-harm.However, it was confirmed that there was no serious injury or harm to the patient as a result of the alleged event.
 
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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 1 R6
CA  N6E 1R6
Manufacturer (Section G)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
N6E 1 R6
CA   N6E 1R6
Manufacturer Contact
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7065194
MDR Text Key93311029
Report Number3006433555-2017-00197
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5800000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2017
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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