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

Model Number 781196

Device Problem Insufficient Information (3190)

Patient Problem Hearing Loss (1882)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will be sent to the fda.

Event Description

Philips received a report from a customer related to a patient who complained of a hearing loss after an mr examination on an achieva 1.5t mr system.The patient was positioned feet first supine and was scanned for a right knee examination.

Manufacturer Narrative

The actual acoustic noise level that is produced by an mri system depends on the type of mr, the configuration and the used scan protocols (examcard).Also the local situation may have influence on this level.The actual used exam card and log-files were requested and used to determine an approximate acoustic noise produced on the mr system.A similar mr test configuration and the exam card involved were used to determine the sound levels.In total 7 scans were conducted with sound pressure levels (spl) varying between 94.9 db and 113.7 db, with an average of 100.4 dba (laeq).The total scan time was 24 minutes 35 seconds.The patient was protected against acoustic noise by single hearing protection (philips headset).The acoustic noise level produced by the gradient chain is within safe limits with the single hearing protection applied.The music played with the audio chain may have contributed to the hearing problems, in case of maximum volume without using earplugs.

• Brand Name: ACHIEVA 1.5T NOVA
• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 7099449
• MDR Text Key: 94231275
• Report Number: 3003768277-2017-00104
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K052013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781196
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Date Device Manufactured: 01/21/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 72