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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER CORPORATION; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number N3A02BCEFMNP1
Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 10/25/2020
Event Type  malfunction  
Event Description
Patient was attempting to stand up to get out of her bed, and "scooted" to the edge of the bed to where her feet were hanging over the side of the bed.Her feet were slightly off of the ground, and she stated all of a sudden while she was sitting on the edge of the bed, she felt like she was falling, and the bed actually rolled fully onto its side.When she stood up, it was still on its side, and had to be placed down to be on all four wheels again.The patient was a little sore, but otherwise unharmed.Another patient had cpr performed on them on that very bed a few days before.We are unsure if this had a hand in this incident.
 
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Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER CORPORATION
3800 e. centre ave
portage MI 49002
MDR Report Key10683081
MDR Text Key211480466
Report Number10683081
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 Other Health Care Professional
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberN3A02BCEFMNP1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/01/2020
Device Age5 YR
Date Report to Manufacturer10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24820 DA
Patient Weight90
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