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

Model Number 781341

Device Problem Temperature Problem (3022)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Based on the provided information and tests performed on site, there is no indication of a malfunction of the mri system or coil used that contributed to the injury.The blistering on both thumb and buttocks is explained by the direct contact between the patient¿s thumb and buttock.No other contributing factors were identified.

Event Description

Philips received a report from a customer related to a heating incident with the posterior coil on an ingenia 1.5t system.A patient received a 3 centimeter blister on both the buttock and thumb.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 8839381
• MDR Text Key: 152602954
• Report Number: 3003768277-2019-00060
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: (01)00884838055322
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 86