MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBI DIAGNOST R90; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 709031

Device Problems No Display/Image (1183); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  Injury  

Event Description

Patient undergoing image guided lumbar puncture.During procedure fluoroscopy system failed; no warning or error message.Fluoro image suddenly turned to gray screen.Case was able to be completed using spot images and patient suffered no permanent harm.However, this event was the second time this scenario happened in a few weeks on the same exact unit (see submitted report dated 2/23/2023).Device was initially serviced by philips team members after 2/23/2023 event and returned to service.Unit has now been taken out of use and reported to philips again.Unit is under philips warranty.Site id (b)(4).

• Brand Name: COMBI DIAGNOST R90
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH
• MDR Report Key: 16513175
• MDR Text Key: 311045284
• Report Number: MW5115592
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 709031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White