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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS MDET TAXABLE; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS MDET TAXABLE; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 0000000001
Device Problems Entrapment of Device (1212); False Reading From Device Non-Compliance (1228)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2017
Event Type  malfunction  
Manufacturer Narrative
Once the shipping pins were removed from the unit, the scale functioned properly.
 
Event Description
It was reported by service report that the scale was inaccurate due to shipping pins being left in the unit.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
MDET TAXABLE
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6389704
MDR Text Key69742426
Report Number3006433555-2017-00042
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 company representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0000000001
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2014
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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