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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
Catalog Number 5700000000
Device Problems False Reading From Device Non-Compliance (1228); Device Tipped Over (2589)
Patient Problems Abrasion (1689); Fall (1848)
Event Date 04/06/2018
Event Type  malfunction  
Event Description
It was alleged that the bed tipped over with a patient and that the patient received minor scratches and abrasions which did not require medical intervention.Upon evaluation no defects were found that would have caused or contributed to the alleged tip.Further, upon evaluation it was found that the scale was inaccurate, however, no defects were found that would have caused or contributed to the inaccurate scale.It was reported that the inaccurate scale may have been caused by a use of device issue.
 
Manufacturer Narrative
Medwatch 3500a # (b)(4).It was additionally reported that the reported abrasion to the arm was treated with a dressing and that the patient complained of pain to the left arm.An x-ray was performed on the left arm with negative results, and the patient later stated that he was no longer in pain.
 
Event Description
It was alleged that the bed tipped over with a patient and that the patient received minor scratches and abrasions which did not require medical intervention.Upon evaluation no defects were found that would have caused or contributed to the alleged tip.Further, upon evaluation it was found that the scale was inaccurate, however, no defects were found that would have caused or contributed to the inaccurate scale.It was reported that the inaccurate scale may have been caused by a use of device issue.
 
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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
MDR Report Key7485234
MDR Text Key107450407
Report Number3006433555-2018-00105
Device Sequence Number1
Product Code FNL
UDI-Device Identifier07613327284546
UDI-Public07613327284546
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5700000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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