MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. MR 7700

Model Number	MR 7700
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation.When completed a follow-up will be sent.
Event or Problem Description
Philips received a report of a failing gradient coil, causing a burning smell and tripping the smoke detector.
Additional Manufacturer Narrative
On 23-jan-2023 philips was notified by a customer that the smoke detector interlock of the mr 7700 system, model number 782120 with srn (b)(6) in herlev, denmark, had detected smoke and that further scanning was prevented.The customer noticed that the lights on the smoke detector device lighted up red and a user message was displayed (¿smoke detector alarm 1: smoke detected.Please check examination room and contact philips service¿).There was a patient in the mr system at the time of the event, this patient was safely removed from the mr system and exam room.The customer indicated that no smoke was seen, but there was a smell of smoke in the technician room.No patient, personnel or bystander was injured.The source of the reported smoke in the technical room was investigated and the cause was found.No visual damage was seen while performing the troubleshooting steps which could be done without dismantling big parts such as the body coil and gradient coil.It was then decided to replace the gradient coil based on information from the logfiles (specific gradient related scan aborts and spike artifact logging).During the dismantling of the gradient coil, it was discovered that the y saddle solder connection of the gradient coil wb30s with 12nc 459800018881 and serial number (b)(6) was damaged from overheating.There was no smoke in the exam room observed, as the system air-cooling transported the smoke originating between the gradient coil and the body coil (so inside the system covers) to the technical room (which is by design).
Additional Manufacturer Narrative
On 23-jan-2023 philips was notified by a customer that the smoke detector interlock of the mr 7700 system, model number 782120 with srn (b)(6) in (b)(6), had detected smoke and that further scanning was prevented.The customer noticed that the lights on the smoke detector device lighted up red and a user message was displayed (¿smoke detector alarm 1: smoke detected.Please check examination room and contact philips service¿).There was a patient in the mr system at the time of the event, this patient was safely removed from the mr system and exam room.The customer indicated that no smoke was seen, but there was a smell of smoke in the technician room.No patient, personnel or bystander was injured.The source of the reported smoke in the technical room was investigated and the cause was found.No visual damage was seen while performing the troubleshooting steps which could be done without dismantling big parts such as the body coil and gradient coil.It was then decided to replace the gradient coil based on information from the logfiles (specific gradient related scan aborts and spike artifact logging).During the dismantling of the gradient coil, it was discovered that the y saddle solder connection of the gradient coil wb30s with 12nc 459800018881 and serial number (b)(6) was damaged from overheating.There was no smoke in the exam room observed, as the system air-cooling transported the smoke originating between the gradient coil and the body coil (so inside the system covers) to the technical room (which is by design).On 05-sep-2024 correction was made to the date received by mfg.

• Brand Name: MR 7700
• Common Device Name: MR 7700
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 16264585
• Report Number: 3003768277-2023-00617
• Device Sequence Number: 19929961
• Product Code: LNH
• UDI-Device Identifier: 00884838104112
• UDI-Public: 00884838104112
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K223442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MR 7700
• Device Catalogue Number: 782120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 01/20/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 05/17/2023; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown