MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 459800614511

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed, a follow-up will sent to the fda.(b)(4).

Event Description

Dose not updating after change to bolus.

Manufacturer Narrative

In this case, the dose calculation is using a previously acquired bolus instead of the current bolus, so the larger the difference in bolus, the larger the difference in dose.Other than in areas affected by bolus, the difference will not be extreme because patient shape and patient density does not vary.The resultant dose calculation may then be observed using any dose evaluation method.Therefore, other perceptions of error could be seen as incorrect dvh, incorrect point dose, incorrect visualization, or incorrect dose statistics.The high visibility of the dose calculation and the required quality checks prior to administering the dose concluded that the probability of this event causing harm is not possible.

Event Description

Dose not updating after change to bolus.

• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 5520 nobel drive, suite 125; fitchburg WI 53711
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; fitchburg WI
• Manufacturer Contact: jill kaeder ; 5520 nobel drive, suite 125; fitchburg, WI 53711
• MDR Report Key: 6022091
• MDR Text Key: 57256631
• Report Number: 3004022368-2016-00002
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 459800614511
• Device Lot Number: 1029QAD06F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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