MAUDE Adverse Event Report: PRIMUS MEDICAL LLC TL500

Model Number TL500RH

Device Problem Material Integrity Problem (2978)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

Customer called stating that they have a bed frame with a weld that broke.

Manufacturer Narrative

The bed frame was inspected by primus medical on (b)(4) 2015.The inspection determined that the bracket where the bed actuator mounts onto the backbone of the bed frame separated.A new bed frame was delivered to the facility on (b)(4) 2015.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 11/04/2011, on two removed sections from the bed-frame where the weld broke state (1) both fractures had occurred at the hear affected weld zone at the toe of the attachment welds; (2) there was significant distortion of the 1 x 2 inch rectangular tube typical of a high bending moment stress; (3) the welding process employed ((b)(4)) was not suitable for the materials and thicknesses being joined; (4) weld size was excessive; (5) heat input was excessive; (6) technique was poor resulting in excessive weld [p]latter and leaving from one to two inches of electrode (wirer) at weld terminations; (7) weld penetration into the attachments was satisfactory however penetration into the tube was minimal; and (7) 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 approx 15 degrees off of horizontal.Add'l mfr narrative: the failure appears to have been caused by the application of an overloaded stress with undetermined bending moment.The welding deficiencies did not cause the fractures but may have been a contributing factor.

• 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: 4531622
• MDR Text Key: 5545268
• Report Number: 3007538326-2015-00003
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: TL500RH
• Device Catalogue Number: SP01-TL500RH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0067-2015
• Patient Sequence Number: 1