MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE (R) 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 10/20/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The bed frame was inspected by primus medical on 10/21/2014.The inspection determined that the bracket where the head high-low actuator mounts onto the backbone of the bed frame separated.A new bed frame was delivered to the facility on (b)(4) 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 (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 ((b)(4)) 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 welt terminations; welt 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.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: PRIME CARE (R) B900
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: layla morris ; 8401 southern blvd.; boardman, OH 44512 ; 3309659681
• MDR Report Key: 4253518
• MDR Text Key: 4992365
• Report Number: 3007538326-2014-00139
• 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: 11/04/2014

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: 10/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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