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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE, INC. DOLPHIN BARIATRIC BED; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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JOERNS HEALTHCARE, INC. DOLPHIN BARIATRIC BED; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Device Problem Deflation Problem (1149)
Patient Problem Cardiac Arrest (1762)
Event Date 01/28/2015
Event Type  No Answer Provided  
Event Description
Patient was in a dolphin bariatric bed; a rapid response was called on patient for respiratory distress, patient was intubated at bedside, and was then coded for asystole.Patient needed to be moved to icu.Side rails were taken down and the sides of bed were put in.We were unable to get the bed out of the room due to the mattress getting stuck in the door way; unable to deflate mattress.Icu brought down a regular bed, patient was lifted into icu bed and transferred.This caused a delay in transfer and patient coded in the icu hallway.Nurse managers were at bedside to try to trouble shoot the bed.Report entered to alert manufacturer of safety concern with this low use: high risk cpr deflation valve.The concern is although the bed is able to be deflated to get it out of the patient room and able to be re-inflated in the hallway outside the patient room for transfer, the concern is the time this takes poses a safety risk.Additionally, the mattress when deflated, is not supportive for resuscitative measures (cpr) and should not have a patient on it for any length of time.
 
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Brand Name
DOLPHIN BARIATRIC BED
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
JOERNS HEALTHCARE, INC.
2100 design road
arlington TX 76014
MDR Report Key4530441
MDR Text Key5537510
Report Number4530441
Device Sequence Number1
Product Code FNM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 02/12/2015
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? *
Device Operator Nurse
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2015
Event Location Hospital
Date Report to Manufacturer02/20/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/12/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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