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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
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.
 
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.
 
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Brand NameSPIRIT PLATFORM
Type of DeviceBED, 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 Key252010425
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
0 Patients were 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
Device Catalogue Number5800000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

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