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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLOAT LAL SYSTEM; PATIENT AIR MATTRESS
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JOERNS HEALTHCARE DERMAFLOAT LAL SYSTEM; PATIENT AIR MATTRESS Back to Search Results
Model Number DFLAL-4280-M
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hematoma (1884)
Event Date 10/27/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to the manufacturer by the end user, per the end user, patient fell out of bed and sustained a hematoma on the head.Complaint (b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.The mattress and control unit received at joerns (b)(4) on (b)(6) 2019 and the investigation is in progress.
 
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Brand Name
DERMAFLOAT LAL SYSTEM
Type of Device
PATIENT AIR MATTRESS
Manufacturer (Section D)
JOERNS HEALTHCARE
1032 north 4th street
baldwyn MS 38824
Manufacturer (Section G)
JOERNS HEALTHCARE
1032 north 4th street
baldwyn MS 38824
Manufacturer Contact
felicia banks
2100 design road
arlington, TX 76014
8008260270
MDR Report Key9274776
MDR Text Key200502665
Report Number3009402404-2019-00076
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDFLAL-4280-M
Device Catalogue NumberDFLAL-4280-M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Weight80
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