MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND NELLCOR; OXIMETER

Model Number	N600X-1
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Diminished Pulse Pressure (2606)
Date of Event	11/05/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During home monitoring use the n600x-1 spo2 pulse rate alarm did not go off at the time of patient¿s death.The patient was paralyzed from the neck down, ventilator dependent with a pacemaker and peg tube for feedings.The pacemaker was 10 years old.The patient caregivers informed the police that the device did not alarm at the time of death, and that another monitor (mindray) was being used at the same time to monitor the heartbeat which was decreasing.It was reported that the n600x-1 was reading 60bpm, which was what the pacemaker was set to.Following the event, nhs trust performed 24-hour testing of the n600x-1 and simulated the reduction of pulse and saturation and the device alarmed as normal.Per the reporter the patients cause of death was pneumonia.The device it not related to the cause of death.
Additional Manufacturer Narrative
Correction: b2, h1 additional information: a2 (age at event, date of birth).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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the battery had failed as the device was an aftermarket battery not approved by medtronic and was expired.It was reported that the monitor displayed higher readings than expected.The reported issue was 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.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11157932
• Report Number: 8020893-2021-00012
• Device Sequence Number: 3583680
• Product Code: DQA
• UDI-Device Identifier: 10884521181229
• UDI-Public: 10884521181229
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: N600X-1
• Device Catalogue Number: N600X-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 07/13/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/08/2021; 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR