MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE ICT SP

Model Number 728311

Device Problems Break (1069); Noise, Audible (3273)

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

Event Type  No Answer Provided  

Event Description

The customer reported noisy motion when moving the patient support up and down.The philips field service engineer (fse) confirmed that no rescan was necessary and there was no report of un-commanded motion.There was no harm to a patient or operator.The fse determined the noise was caused by a failed ball screw and a failed bearing of the vertical drive, and replaced these failed parts to resolve the issue.

Manufacturer Narrative

(b)(4).Note: we have not completed our investigation of this event and therefore cannot complete sections h1-h9 at this time.We will file a follow-up mdr at the completion of the investigation.(b)(4).

• Brand Name: BRILLIANCE ICT SP
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 4222981
• MDR Text Key: 5068338
• Report Number: 1525965-2014-00178
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 10/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1