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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE CHIP MEDICAL PRODUCTS INC. POWERTURN ELITE MATTRESS
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BLUE CHIP MEDICAL PRODUCTS INC. POWERTURN ELITE MATTRESS Back to Search Results
Model Number 9800
Device Problem Material Separation (1562)
Patient Problems Abrasion (1689); Fall (1848); Laceration(s) (1946); Injury (2348)
Event Date 08/08/2014
Event Type  Injury  
Event Description
Resident was placed on air mattress 4 days prior to incident as part of a treatment plan for pressure ulcers on resident's back.Resident had been on the mattress for 4 days without incident.On (b)(6) 2014 at 5:10pm resident could be heard yelling out for help.When staff entered room, resident was found on floor with mattress laying upside down on top of him.Resident was taken to emergency dept where he received sutures to a laceration to his forehead and surgical adhesive to a laceration on his chin.He also sustained abrasions to his knees and a large skin tear to his right elbow.Straps that held the powerturn elite mattress to the bed frame separated from the powerturn elite mattress.
 
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Brand Name
POWERTURN ELITE MATTRESS
Type of Device
POWERTURN ELITE MATTRESS
Manufacturer (Section D)
BLUE CHIP MEDICAL PRODUCTS INC.
suffern 10901
MDR Report Key4024961
MDR Text Key4843027
Report NumberMW5037779
Device Sequence Number1
Product Code FNM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9800
Device Catalogue Number75388
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age71 YR
Patient Weight71
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