MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781342

Device Problem Device Fell (4014)

Patient Problem Eye Injury (1845)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still ongoing on 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 an incident during an mr examination.A mirror that was used on a coil during this examination fell and hit the patient's right eye.

Manufacturer Narrative

The mirror is supplied by an approved vendor on the approved supplier list (asl).The supplier of the mirror analyzed the problem and two causes were identified: 1.The mirrors were not always assembled to completion: the sampling plan was not 100% validating that the screws were in place and engaged.2.It was observed that the mirror (related to incident tw8779156) was unassembled after it was shipped by the supplier.It was concluded that the drawing in revision 1 of the assembly instructions was showing the mirror in the opposite direction.Measures taken via supplier corrective action (scar-19-001) and non-conformity report (ncr#36101): 1.The supplier has implemented a 100% visual inspection after assembly, assuring that the screws are in place and the engagement of the screw will be 100% validated as well.2.All orders going forward will be made according to revision 2 of the assembly instructions.Thus the mirrors will be positioned correctly when leaving the supplier and there is no need for reassembly in the field.3.All parts in stock will be checked and reworked according the updated work instructions.4.An inspection will be performed when the next lot comes in, to ensure all parts are correct.A health hazard evaluation (hhe-mr-1094-2019) was performed to evaluate the situation and it was determined that the associated risk was acceptable.Additional information was received that there was no permanent injury and it healed without special treatment.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 3.0T
• 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: 8124333
• MDR Text Key: 129037114
• Report Number: 3003768277-2018-00089
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 781342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 50