MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE (R) TRANSCEND MATTRESS

Model Number TCM3580

Device Problems Nonstandard Device (1420); Delamination (2904)

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

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Upon receipt of the recall packet, the customer notified the firm they had a delaminated mattress.

Manufacturer Narrative

Upon inspection of this mattress, the urethane cover bubbled at the center of the mattress cover but did not expose the inside foam.A new mattress was delivered out to the facility 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 (R) TRANSCEND MATTRESS
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: mark hudson ; 5850 klockner dr.; richmond, VA 23231 ; 8042261155
• MDR Report Key: 4173116
• MDR Text Key: 5091326
• Report Number: 3007538326-2014-00115
• 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: 10/01/2014

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: TCM3580
• Device Catalogue Number: SPO3-TCM3580
• Device Lot Number: 042012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2596-2014
• Patient Sequence Number: 1