MAUDE Adverse Event Report: ANGELICA CORP ANGELDERM; PROTECTOR, SKIN PRESSURE

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2016

Event Type  malfunction  

Event Description

An intubated and sedated patient was taken to the mri with a nurse and respiratory therapist (rt) for a head and neck scan.The travel requires coordination with medications given/ordered, staff to be available to travel off unit, and coordination with mri to secure an available time for scan.The patient was prepared for the mri by removing all known-metal objects and placed on mri monitor/vent.Once in mri the metal detector was used over the pt by the mri staff and pt was cleared to go into scanner.The c-spine mri was done first and no issues arose.Once the brain mri began, the first image was noted to have a lot of "artifact" by the mri tech, an "unusable" image, and the scan was repeated.The repeat image was again abnormal therefore the rt was paged and we had to take the pt out of the scanner twice to determine what was causing the artifact and it was the green pad linen pad under the patient's head that contained a "angelica" white label on it that was not detected by the metal detector but did have enough artifact to cause the scan to be unreadable.The total time to complete the mri was 2 hours when it should have been less than one.Suggestion: remove all linens with metal tag labels reading "angelica" from patient settings to avoid harm to patient and delay in care with mri.No patient factors involved in this event - no harm to the patient other than to delay a critically-ill patient in completing the mri scan.This event is related to metal contained within the linen that impacts that mri imaging.This is an odd event and i am grateful for the nurse that reported it initially.I am not sure that we have anything else to add about this - would be happy to hear from angelica if there is some level of metal in the green linen pad that could impact an mri scan.

• Brand Name: ANGELDERM
• Type of Device: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): ANGELICA CORP; 1105 lakewood parkway; suite 210; alpharetta GA 30009
• MDR Report Key: 5920536
• MDR Text Key: 53726703
• Report Number: 5920536
• Device Sequence Number: 1
• Product Code: FMP
• 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: 08/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: GREEN LINEN PAD WITH PRINTED
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: GREEN LINEN PAD THAT THE PATIENT WAS LYING ON DURI
• Patient Age: 54 YR