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

Model Number MAXFASTI

Device Problems Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)

Patient Problem Bruise/Contusion (1754)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the sensor was connected to the patient's forehead and when they shifted the place of the sensor, they found a bruise over the place they had connected the sensor.The patient's forehead got wound.The device had physical damage.

• 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: 9379786
• MDR Text Key: 168437585
• Report Number: 2936999-2019-00973
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884522039697
• UDI-Public: 10884522039697
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: MAXFASTI
• Device Catalogue Number: MAXFASTI
• Device Lot Number: 173030088H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/26/2019
• Date Device Manufactured: 10/31/2017
• 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