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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINET AMERICAS MULTICARE; BED, PATIENT ROTATION, MANUAL
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LINET AMERICAS MULTICARE; BED, PATIENT ROTATION, MANUAL Back to Search Results
Model Number 56011347B-02
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2016
Event Type  malfunction  
Event Description
The patient's bed froze while the patient was in rotation mode at 15 degrees.The patient was a critically ill patient in ards that required rotation for her illness.We tried everything to fix the bed such as turning it off, unplugging it, pushing every button etc.Error code 4 and 13 appeared on the screen.We had to move the patient to a new bed with her at 15 degrees.This not only was potentially dangerous for the patient but it could have caused harm to our staff.
 
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Brand Name
MULTICARE
Type of Device
BED, PATIENT ROTATION, MANUAL
Manufacturer (Section D)
LINET AMERICAS
10420 harris oaks blvd.
suite r
charlotte NC 28269
MDR Report Key6054067
MDR Text Key58297363
Report Number6054067
Device Sequence Number1
Product Code INY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/18/2016,10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2016
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number56011347B-02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2016
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age62 YR
Patient Weight51
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