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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMUS MEDICAL, LLC PRIME CARE TRANSCEND MATTRESS
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PRIMUS MEDICAL, LLC PRIME CARE TRANSCEND MATTRESS Back to Search Results
Model Number TCM3580
Device Problems Delamination (2904); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2014
Event Type  malfunction  
Event Description
Mattress cover is delaminating.
 
Manufacturer Narrative
Upon inspection of this mattress, the urethane cover bubbled at the center of the mattress cover but did not peel away exposing the foam of the mattress.This mattress has been isolated in the non-conforming room until investigation is complete and mattress has been dispositioned.A new mattress was delivered to the facility on (b)(4) 2014.This problem has been assigned to capa (b)(4), and a f/u report will be submitted upon completion of the correction action.
 
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Brand Name
PRIME CARE TRANSCEND MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL, LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner dr.
richmond, VA 23231
8042261155
MDR Report Key3814950
MDR Text Key4389838
Report Number3007538326-2014-00037
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 04/21/2014
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 Other
Device Model NumberTCM3580
Device Catalogue NumberSP03-TCM3580
Device Lot Number042012
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/16/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/08/2014
Initial Date FDA Received04/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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