MAUDE Adverse Event Report: SEDECAL SA PHILIPS; MOBILE DIAGNOSTIC X-RAY SYSTEM

Model Number	MOBILEDIAGNOST WDR
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
This is a mobile diagnostic x-ray unit.The collimator on the unit was serviced.As a result of improper re-attachment, the collimator fell off the tube-head during subsequent use.It was then left dangling by its cable.No one was injured.A service person subsequently re-attached the collimator in a proper fashion.

• Brand Name: PHILIPS
• Common Device Name: MOBILE DIAGNOSTIC X-RAY SYSTEM
• Manufacturer (Section D): SEDECAL SA; pelaya, 9 .; pol. ind. rio de janeiro; algete,, madrid 28110 ,; SP 28110,
• MDR Report Key: 7984277
• Report Number: 9617251-2018-00002
• Device Sequence Number: 10813290
• Product Code: IZL
• UDI-Device Identifier: 08436046002173
• UDI-Public: 08436046002173
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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
• Operator of Device: Health Professional
• Device Model Number: MOBILEDIAGNOST WDR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1