MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO. LTD. DURADIAGNOST; SYSTEM, X-RAY, STATIONARY

Model Number 712211

Device Problem Component Falling (1105)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was under installation, not handover to customer for use.When investigation is completed, a follow up report will be sent to fda.See scanned page.

Event Description

Phillips received a report from a customer that the tube arm fell down from stand during installation.No harm reported.

• Brand Name: DURADIAGNOST
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS HEALTHCARE (SUZHOU) CO. LTD.; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 5811932
• MDR Text Key: 50288678
• Report Number: 3009529630-2015-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2015

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: 712211
• Device Catalogue Number: 712211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2015
• Initial Date FDA Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1