MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE B900

Model Number PCB900RH

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 11/03/2014

Event Type  malfunction  

Event Description

Upon receipt of the recall packet, the customer notified the firm they had a bed frame with the actuator weld starting to separate.

Manufacturer Narrative

This bed frame was inspected by primus on 11/04/2014.The inspection determined that the bracket where the head actuator mounts onto the backbone of the bed frame separated.A new bed frame was sent to the facility on 11/03/2014.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 that both fractures had occurred at the head affected weld zone at the toe of the attachment welds; that there was significant distortion of the 1 x 2 inch rectangular tube typical of a high bending moment stress; that the welding process employed (gmaw) was not suitable for the materials and thicknesses being joined; that weld size was excessive; that heat input was excessive; that technique was poor resulting in excessive weld splatter and leaving from one to two inches of electrode (wirer) at weld terminations; that weld penetration into the attachments was satisfactory; however, penetration into the tube was minimal; and that 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.The failure appears to have been caused by the application of an overload stress with an undetermined bending moment.The welding deficiences did not cause these fractures but may have been a contributing factor.

• Brand Name: PRIME CARE B900
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: layla morris ; 8401 southern blvd; boardman, OH 44512-0000 ; 3309659681
• MDR Report Key: 4253132
• MDR Text Key: 5013125
• Report Number: 3007538326-2014-00146
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PCB900RH
• Device Catalogue Number: SP01-PCB900RH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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-0067-2015
• Patient Sequence Number: 1