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

Model Number 781296

Device Problem Overheating of Device (1437)

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

Event Date 09/04/2019

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 on an achieva 1.5t mr system.A female patient sustained a second degree injury on the back of both knees.

Manufacturer Narrative

Conclusion: based on the provided information and test performed on site the mr system and coil used are not suspected to have contributed to the event.The injury is consistent with heating incidents caused by contact with conductive material.In this case, the object that caused the burn was not identified.When the instructions for use are followed, such a heating incident would not be possible.Contributing factors in this case: 7 scans with high sar values (> 2 w/kg and up to 4 w/kg) were executed in a short period of time, allowing no cool down time for the patient.The total administered specific energy dose of 4.8 kj/kg exceeded the recommended limit of 3.5 kj/kg.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: ACHIEVA 1.5T NEW
• 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: 9375153
• MDR Text Key: 167976945
• Report Number: 3003768277-2019-00095
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K063559
• 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: 11/08/2019

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: 781296
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 65