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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
Model Number 5700
Device Problems Bent (1059); False Reading From Device Non-Compliance (1228)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
Unit was replaced for the customer.
 
Event Description
It was reported the scale was inaccurate due to a bent bed frame.No patient was affected and no adverse consequence 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.
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 Key7300130
MDR Text Key101248786
Report Number3006433555-2018-00060
Device Sequence Number1
Product Code FNL
UDI-Device Identifier07613327284546
UDI-Public(01)07613327284546
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5700
Device Catalogue Number5700000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2015
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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