MAUDE Adverse Event Report: ALLIANCE HEALTHCARE SERVICES MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Cataract (1766); Cyst(s) (1800); Eye Injury (1845); Flashers (1864); Pain (1994); Blurred Vision (2137); Burning Sensation (2146); Twitching (2172); Depression (2361); Vitreous Detachment (2445); Superficial (First Degree) Burn (2685); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 10/03/2020

Event Type  Injury  

Event Description

Pt states that she received a routine mri to rule out back pain and that she was instructed to wear a surgical mask with the metal nose-piece.Pt reports that she asked the mri technician many times whether it was safe to wear her mask during the mri and was told there would be no cause for concern.Pt also reports that the tech left her shoes , which she notes were cloth, directly under the machine.Pt states that during mri she felt a burning sensation in her back and began having twitching in her left eye.Pt notes that in the past, she has never experienced these sensations when having an mri.Pt states that after she left she noticed a burn mark on her nose where the mask was placed.Pt also reports that the next day she woke up with extensive swelling and inability to see from her left eye due to a chalazion cyst on the tip of her eyelid.Pt reports that she saw several eye specialists about the cyst due to the size, was told to use hot compresses and eventually put on antibiotics that she stated were not helpful.Pt notes that she did not lance the cyst due to potential for scarring and that after several months the cyst subsided after use of hot compresses but left residual swelling in her left eye lid.Pt also reports that about 2 weeks after mri procedure she had flashes from the corner of her left eye and that her eye specialist informed her she was having vitreous detachment and that she would continue to see the flashes until complete detachment of the vitreous.Pt states that her vitreous did detach and that she was seen by a retinal specialist due to the concern of potential retinal detachment because her vitreous had detached so quickly.Pt states that her optic nerve in both eyes are thinning and that she has the beginning of bilateral cataracts.Pt reports eye pain, blurred vision, pressure, depression due to loss of her job since the incident, and occasional persisting sharp pain in her left eye which has prompted a follow up with mass eye and ear.Pt states that her eyesight was 20/15 and 20/20 but now she has 20/25 vision in her left eye.Pt states that she spoke with hospitals in the area about mri protocol during covid and was told that all masks with metal are removed and replaced with tape.Of note, pt states that the mri tech was employed by alliance and she spoke with alliance about the incident but has not received any follow up and help.

• Brand Name: MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): ALLIANCE HEALTHCARE SERVICES; 18201 von karman avenue; ste 600; irvine CA 92612
• MDR Report Key: 12266984
• MDR Text Key: 265054425
• Report Number: MW5102949
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 56 YR