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 10/30/2013

Event Type  malfunction  

Event Description

Customer called in and stated that the head deck bolt from the head actuator weld broke on their bed.

Manufacturer Narrative

The bed frame was inspected by the firm and it was determined that the bracket where the head actuator mounts onto the backbone of the bed frame broke off.A new bed frame was delivered to the facility on (b)(6)2013.This problem has been assigned capa (b)(4) , and a follow-up report will be submitted upon completion of the corrective action.Metallurgical analysis report, dated (b)(4) 2011, on two removed sections from the bed-frame where the weld broke state both fractures had occurred at the heat affected weld zone at the toe of the attachment welds; there was significant distortion of the 1 x 2 inch rectangular tube typical of a high bending moment stress; the welding process employed (gmaw) was not suitable for the materials and thicknesses being joined; weld size was excessive; heat input was excessive; technique was poor resulting in excessive weld [s]platter and leaving from one to two inches of electrode (wirer) at weld terminations; weld penetration into the attachments was satisfactory however penetration into the tube was minimal; and examination of the wear pattern on the lever holes suggest a straight tension loading and the clevis holes indicate a push-pull load which is approximately 15 degrees off of horizontal.A review of complaints took place and the firm has concluded that this complaint should have been filed as a mdr.The bed frame had the right and left head deck pivot point bolt shear causing the head section of the bed to detach from the mid-section of the bed frame.During the review of complaints there were similar occurrences that the firm found and have filed mdrs for these complaints as well.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: 4324796
• MDR Text Key: 15818327
• Report Number: 3007538326-2014-00166
• 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: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• 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: 10/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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