MAUDE Adverse Event Report: SEDECAL S.A. MOBILEDIAGNOST WDR 2.2; SYSTEM, X-RAY, MOBILE

Model Number	712006
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer in the us reported that their mobilediagnost wdr 2.2 system was non-operational as the user could not log in.The customer had multiple units at six different sites that were affected.The customer further stated that "patient care was significantly affected as no portable x-rays were able to be conducted for two days".Philips has received multiple medwatch reports for the reported events from this healthcare facility.For the reported event that is in the scope of this report (medwatch report mw 5117657), the complainant completed section "adverse event or product problem" of the medwatch form with the field "outcomes attributed to adverse event" listed as "life threatening".In addition, the complainant completed the medwatch report form section "device manufacturers only" with the field "type of event listed as "serious injury".Philips has made multiple attempts to get further information regarding the alleged "patient injuries", and the alleged "life threatening event".So far, philips has not received any additional information regarding these events from the complainant.We are reporting this event out of abundance of caution.Our investigation of this event is on-going.We will provide a follow-up report upon completion.

• Brand Name: MOBILEDIAGNOST WDR 2.2
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SEDECAL S.A.; pelaya 9-13; pol ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• MDR Report Key: 17192885
• Report Number: 3016618143-2023-00001
• Device Sequence Number: 7333529
• Product Code: IZL
• UDI-Device Identifier: 08436046002357
• UDI-Public: (01)08436046002357
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/23/2023
• Report Date (Section F): 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 712006
• Device Catalogue Number: 712006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/18/2023