MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

Model Number	MAXFASTI
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Septic Shock (2068); Pressure Sore/Ulcer (2326)
Date of Event	09/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the product caused a pressure injury from the band tension.On day 11, a stage two pressure sore was discovered under the band and rapidly developed a stage three pressure sore on the occipital area.It was reported that a debridement was necessary.There was a subsequent discharge from the intensive care unit and plastic surgery was considered but the sore was apparently healing well, and plastic surgery deemed unnecessary.It was indicated that a bald patch was left where a device band was and had no hair regrowth.The patient had a medical history of head trauma with the presence of edema and was diagnosed with septic shock 10 days before the decubitus ulcer formation.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 11087689
• Report Number: 2936999-2020-00951
• Device Sequence Number: 14125501
• Product Code: DQA
• UDI-Device Identifier: 20884522039694
• UDI-Public: 20884522039694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAXFASTI
• Device Catalogue Number: MAXFASTI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR