MAUDE Adverse Event Report: PRIMUS MEDICAL LLC TL500

Model Number TL500

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

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

Event Date 09/05/2013

Event Type  malfunction  

Event Description

Customer called in and stated that one of the deck bolts from their bed broke.

Manufacturer Narrative

After a review of complaints took place the firm has concluded that this complaint should have been filed as an mdr.The bed frame was evaluated and it was found that one of the head deck bolts sheared off.The bed frame was brought back for repair and then returned to the facility.During the review of complaint, there were no additional complaints of similar occurrences and the firm is monitoring for any future complaints.

• Brand Name: TL500
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: layla morris ; 8401 southern blvd; boardman, OH 44512 ; 3309659681
• MDR Report Key: 4268634
• MDR Text Key: 5298314
• Report Number: 3007538326-2014-00140
• Device Sequence Number: 1
• Product Code: FNL
• 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: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: TL500
• Device Catalogue Number: SP01-TL500RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1