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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 12/22/2017
Event Type  Injury  
Manufacturer Narrative
No defects were alleged with the unit, and the issue was resolved for the customer by confirming no further assistance was required.
 
Event Description
It was reported that the user was attempting to re-position the bed and in the process received an unspecified elbow injury. It was further reported that this caused the user to be unable to lift weight, but no details of any possible medical intervention were given. No defects were alleged with the bed, and no patient involvement was reported.
 
Manufacturer Narrative
It was reported that this event resulted in a worker's compensation claim, but no details regarding the claim were given.
 
Event Description
It was reported that the user was attempting to re-position the bed and in the process received an unspecified elbow injury. It was further reported that this caused the user to be unable to lift weight, but no details of any possible medical intervention were given. No defects were alleged with the bed, and no patient involvement was reported.
 
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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
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7203674
MDR Text Key113308744
Report Number3006433555-2018-00016
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5800000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/16/2015
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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