MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FLEXTRAK OR INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 989603051341

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Event Description

Head coil is having troubles latching.Discovered the latch is broken and there are several places on the coil that have cracks and slivered plastic.We use the pdi super sani-cloth germicidal disposable wipe to clean the coils after patient use as recommended by philips.However according to the pdi website these wipes are intended for "hard non-porous surfaces".It is not clear if the coil plastic is porous or not.

• Brand Name: FLEXTRAK OR INGENIA 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3600 sw 47th avenue; gainesville FL 32608
• MDR Report Key: 6800223
• MDR Text Key: 82896825
• Report Number: 6800223
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 989603051341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO