MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PIME CARE (RN) TRANSCEND ADVANCED MATTRESS

Model Number TACM3580

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

Customer emailed stating that they had a mattress that was delaminated.

Manufacturer Narrative

Upon review of the picture sent from the customer the urethane cover bubbled at the center of the mattress exposing the inside of the mattress cover.A new mattress was shipped out to the customer on 03/13/2015.This problem has been assigned to cpa (b)(4), anf a follow-up report will be submitted upon completion of the corrective action.

• Brand Name: PIME CARE (RN) TRANSCEND ADVANCED MATTRESS
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: mark hudson ; 5850 klockner dr.; richmond, VA 23231 ; 8042261155
• MDR Report Key: 4680317
• MDR Text Key: 17294996
• Report Number: 3007538326-2015-00020
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/03/2015

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?: No
• Device Operator: Other
• Device Model Number: TACM3580
• Device Catalogue Number: SP03-TACM3580
• Device Lot Number: 061412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z2596-2014
• Patient Sequence Number: 1