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

Model Number MAXFASTI

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Septic Shock (2068); Pressure Sores (2326)

Event Date 09/12/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11087689
• MDR Text Key: 224089584
• Report Number: 2936999-2020-00951
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522039694
• UDI-Public: 20884522039694
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXFASTI
• Device Catalogue Number: MAXFASTI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR