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

Model Number MAX-I-I

Device Problem High Readings (2459)

Patient Problems Death (1802); Pneumonia (2011)

Event Date 07/24/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, the device had high spo2 reading issue.The patient died.Spo2 and pulse rate reading continued for about 20 minutes.A relationship to the device has not been established.The cause of death is unknown.

Manufacturer Narrative

Additional information: (age at event), sex, (weight in lbs), describe event or problem, date received by manufacturer.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the newborn was on high frequency ventilator and the doctor check cardiac signal with echocardiogram and had no cardiac signal, however, the monitor with sensor still showed the value as pr - 190, bp- n/a and spo2-100% for a long time of up to 20 minutes.The device was not attributable to the patient's death.It was reported that the cause of death was due to ttnb congenital pneumonia.

Manufacturer Narrative

Conclusion: the device history records were reviewed for the valves.These device were manufactured per approved and released manufacturing processes and the devices met all applicable manufacturing specifications prior to release for distribution.Without the return of the valve for analysis, a root cause of the regurgitation cannot be determined.Based on the limited information available, the reported thrombus could have led to incomplete coaptation and be the potential cause for the regurgitation.A number of factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditions, and its presence and rate of formation is largely dependent on patient condition.Based on the limited information available, an assignable root cause leading to the thrombus could not be determined.Based on the limited received information, the failure mode cannot be determined.The melody instructions for use (ifu) states ¿the melody¿ tpv is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic pulmonary valve that has = moderate regurgitation, and/or a mean rvot gradient =35 mm hg.¿ medtronic has not submitted the melody for any design related testing for patients who require replacement of their native tricuspid valve nor does medtronic have any data to support the use of melody in the tricuspid position.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the monitor displayed an incorrect reading.It was reported that the monitor displayed higher readings than expected.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

According to the reporter, the newborn was on high frequency ventilator and the doctor check cardiac signal with echocardiogram and had no cardiac signal, however, the monitor with sensor still showed the value as pr - 190, bp- n/a and spo2-100%.The device did not cause patient harm and was not related to the patient death.It was reported that the cause of death was due to ttnb congenital pneumonia.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 10586703
• MDR Text Key: 208540915
• Report Number: 1282497-2020-00039
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522041277
• UDI-Public: 20884522041277
• Combination Product (y/n): N
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: MAX-I-I
• Device Catalogue Number: MAX-I-I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 DA
• Patient Weight: 3