MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE TRANSCEND ADVANCED MATTRESS

Model Number TACM3580

Device Problems Delamination (2904); Material Integrity Problem (2978)

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

Event Date 03/31/2014

Event Type  malfunction  

Event Description

Mattress cover is delaminating.

Manufacturer Narrative

This mattress has not been inspected yet due to the mattress not being returned.The customer is in the process of sending back the mattress to our warehouse.A new mattress was shipped out to the customer on (b)(4) 2014.This problem has been assigned to capa (b)(4), and a follow up report will be submitted upon completion of the corrective action.

• Brand Name: PRIME CARE 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: 3814983
• MDR Text Key: 4400592
• Report Number: 3007538326-2014-00029
• 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
• 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 Number: TACM3580
• Device Catalogue Number: SP03-TACM3580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1