MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781396

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing on this event.When the investigation is completed a follow up will be sent to the fda.

Event Description

Philips received a report from a customer related to a patient heating incident with an ingenia1.5t mr system.A patient was scanned for an mri examination.After the examination a blister was observed on the patient's abdomen.

Manufacturer Narrative

No explanation can be provided for the injury as reported.No information was provided, and after checking with the customer it was stated that no additional information can be made available.The mr system and coils were not tested but no incidents have been reported since.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INGENIA 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8627168
• MDR Text Key: 145613507
• Report Number: 3003768277-2019-00042
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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: 781396
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other