MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTERA 1.5T MASTER/NOVA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781106

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

Philips received a report on a heating incident with an intera 1.5t mr system.

Manufacturer Narrative

Based on the provided information and test performed on site there is no indication of a malfunction of the mr system or coil used that contributed to the event.The blistering on both calves can be explained by skin to skin contact between the calves.It was stated that there was potential for skin to skin contact at the affected area and no padding was used contributing factor found in this case are 4 scans performed on high sar 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: INTERA 1.5T MASTER/NOVA
• 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: 8981733
• MDR Text Key: 157143739
• Report Number: 3003768277-2019-00071
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K001796
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781106
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 103