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

Model Number MAXA

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problems Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, while using the device on the patient, spo2 (peripheral capillary oxygen saturation) was alarming, the pulse oximetry was in the 70¿s in parenthesis and good weight form.The patient was in bed for 5 days with spo2 form ranging 90% to 100%.A new sensor was placed on the patient and prior one had fallen off at 1400 degrees.The monitor alarmed with good weight form and patient was on respiratory distress and new sensor read 100% with same weight form with faulty one.There was patient injury reported.

Manufacturer Narrative

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

Event Description

According to the reporter, while using the device on the patient sp02 was alarming, the pulse oximetry was in the 70's in parenthesis and good weight form.The patient was in bed for 5 days with spo2 form ranging 90% to100%.A new spo2 sensor was placed on the patient and prior one, it had fallen off at 1400 degrees.The monitored alarmed with good weight form and patient was on respiratory distress and new sensor read 100% with same weight form with faulty one.There was no patient injury.

• 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 ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7542302
• MDR Text Key: 109186158
• Report Number: 1282497-2018-00412
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522040089
• UDI-Public: 20884522040089
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: MAXA
• Device Catalogue Number: MAXA
• Device Lot Number: 180470269H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 08/21/2018
• 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): Required Intervention