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

Model Number 781396

Device Problem Overheating of Device (1437)

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

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 from a customer related to a patient heating incident with an anterior coil on an ingenia 1.5t mr system.After the examination, reddening was observed on the inner thighs.Later the patient reported a burn on the shoulder and that blisters developed on the thighs.

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.From the provided information no explanation was found for the injury on the patient's shoulder.As to the injury between the thighs.Although it was stated that padding was used and the legs were not touching where the reddening was observed, no details of the location of the pads were provided.It is therefore concluded that the injury between the patient¿s thighs is caused by skin-to-skin (near) contact.Skin-to-skin contact between the thighs can easily occur, although (near) skin-to-skin contact does not always led to skin-to-skin burns.A contributing factor found in this case are 3 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: 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: 8949185
• MDR Text Key: 156087693
• Report Number: 3003768277-2019-00069
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 95