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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER SECURE III; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER CORPORATION STRYKER SECURE III; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 3005S3PX2
Device Problem Delayed Alarm (1011)
Patient Problems Death (1802); Exsanguination (1841); Fall (1848)
Event Date 10/05/2020
Event Type  Death  
Event Description
Bed alarm did not sound when patient got out of bed.Safety precautions noted in chart prior to event: bed alarm on, bed in lowest position, call bell within reach.Patient was found on floor unresponsive by tech.Pool of blood was noted around base of head.No pulse, code called.As nurse pushed bed out of way, then the bed alarm sounded.Team worked on patient for about 20 minutes, then called.Patient was noted to be a fall risk.Less than 12 hours since last fall risk assessment.Fall risk assessment prior to fall: 9.Risk factors, post-op c1-c2 fracture following mva two weeks prior, weakness, impaired functional status, gait deficit, mobility limitation, balance deficit, impulsive, non-compliant, would not wear c-collar.Floor surface was dry.No restraints at time.No autopsy performed.Stryker rep came and inspected the bed for issues.They submitted their report to the quality team for investigation.Results pending.
 
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Brand Name
STRYKER SECURE III
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER CORPORATION
3800 e. centre ave
portage MI 49002
MDR Report Key10749890
MDR Text Key213506782
Report Number10749890
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3005S3PX2
Device Catalogue Number3005S3PX2
Device Lot Number7124454
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/26/2020
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age26645 DA
Patient Weight94
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