MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980X1ENDIUU

Device Problem Defective Alarm (1014)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the medtronic service engineer (se) inspected the device and ran self-testing.The unit passed testing and operated within the manufacturing specifications.Per review of the logs, there was no indication that there was a loss of ventilation.However, the logs indicated that there was a depleted battery where no alarms were triggered.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that while in use on a patient, the 980 ventilator shut down.Patient intervention and outcome is unknown.Per review of the logs, there was no indication that there was a loss of ventilation.However, the logs indicated that there was a depleted battery where no alarms were triggered.

Manufacturer Narrative

Correction to section h6 evaluation code conclusion.Additional codes added to section h6 patient codes, health impact code and component code.Additional information added to the device evaluation summary: the investigation could not determine an actual cause of the reported event.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: 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 10837702
• MDR Text Key: 216187009
• Report Number: 8020893-2020-00183
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: 10884521171541
• Combination Product (y/n): N
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1