MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PINNACLE3; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 453560461331

Device Problem Application Program Problem: Dose Calculation Error (1189)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the software calculation performance will be included in a follow up report upon investigation completion.

Event Description

A customer reported an srs cone algorithm was incorrectly calculating dosage recommendations.A patient was given an incorrect dosage.However, no injury resulted from this event.

Manufacturer Narrative

Evaluation of the software calculation performance determined the software was functioning as designed with no impact to the patient should the issue reoccur.The dose computation is correct, but depth of computation is not obvious.The prerequisite robust quality assurance program will identify any dose differences.

• Brand Name: PINNACLE3
• 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: 6152548
• MDR Text Key: 62125264
• Report Number: 3004022368-2016-00003
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 453560461331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2016
• 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