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

Model Number MAXFAST

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Skin Erosion (2075)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: n/a - other.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, red ulcer appears to be beneath wear the sensor was situated.Abrasion across from the sensor in the shape of a line appears to be representative of the cord attached to the sensor.Both the cord and the sensor were situated underneath the unit's head band.

Manufacturer Narrative

Evaluation summary: one product was received for evaluation.Previous investigations with sample have not confirmed and skin integrity issues reported for similar products.A possible root cause could be usage (sensor not checked every 3 hrs.Or excessive bandaging causing blisters).No change has been done to the sensors.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• 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, MA 80301 ; 3035306582
• MDR Report Key: 7777276
• MDR Text Key: 116909601
• Report Number: 2936999-2018-00505
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522039717
• UDI-Public: 20884522039717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXFAST
• Device Catalogue Number: MAXFAST
• Device Lot Number: 1881170381H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR