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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE ARISE 1000 EX MATTRESS; PATIENT AIR MATTRESS

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JOERNS HEALTHCARE ARISE 1000 EX MATTRESS; PATIENT AIR MATTRESS Back to Search Results
Model Number AREXLAL-4888-M
Device Problem Inadequate or Insufficient Training (1643)
Patient Problem Fall (1848)
Event Date 03/17/2018
Event Type  malfunction  
Event Description
It was reported to the manufacturer by the end user, per the end user, facility is stating the mattress is to big for frame, mattress is sitting on side rails.Patient fell out of bed.The patient did not sustain any injuries.(b)(4) were entered into our system to have the mattress, control unit and bed returned to joerns for investigation.As of this writing, the mattress, control unit and bed have not been returned.
 
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Brand Name
ARISE 1000 EX MATTRESS
Type of Device
PATIENT AIR MATTRESS
Manufacturer (Section D)
JOERNS HEALTHCARE
avenida pedro hinojosa no.26
ciudad industrial
matamoros, tamaulipas 87499
MX  87499
Manufacturer (Section G)
JOERNS HEALTHCARE
avenida pedro hinojosa no.26
ciudad industrial
matamoros, tamaulipas 87499
MX   87499
Manufacturer Contact
felicia banks
2100 design road
arlington, TX 76014
8008260270
MDR Report Key7398649
MDR Text Key104718070
Report Number3009402404-2018-00014
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/04/2018
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 NumberAREXLAL-4888-M
Device Catalogue NumberAREXLAL-4888-M
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/18/2018
Initial Date FDA Received04/05/2018
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
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