MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980X1ENDIUU

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during use, the pb980 ventilator's alarms were not functioning, as no audible alarm was heard. the patient was removed from the ventilator and placed on an alternate ventilator with no injury reported.

Manufacturer Narrative

Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during use, the pb980 ventilator's alarms were not functioning, as no audible alarm was heard.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not duplicate the reported issue.Additionally, sp checked and found multiple communication errors in the ventilator memory and replaced the user interface (ui) printed circuit board assembly (pcba).The sp also found log initialization error from the memory and replaced the line interface 2 pcba.Sp also replaced a cracked 360 alarm lens.Sp checked and updated the firmware to the latest version.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.The investigation could not determine a cause of the event.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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.

Manufacturer Narrative

Additional information h7 and h9 fda #: z-0966-2022.Section d9 was updated due to part return additional code added to section h6 evaluation code result.Correction to initial report (due to part return) section h6 evaluation code conclusion - remove d15 and add d01 h3 device evaluation summary: updated due to part return medtronic conducted an investigation based upon all information received.It was reported that during use, the pb980 ventilator's alarms were not functioning, as no audible alarm was heard.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not duplicate the reported issue.Additionally, sp checked and found multiple communication errors in the ventilator memory and replaced the user interface (ui) printed circuit board assembly (pcba).The sp also found log initialization error from the memory and replaced the line interface 2 pcba.Sp also replaced a cracked 360 alarm lens.Sp checked and updated the firmware to the latest version.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.A review of logs confirmed the evidence to reported issue.The service personnel (sp) inspected the ventilator but was not able to duplicate the reported issue but found multiple communication errors in memory and replaced user interface (ui) printed circuit board assembly (pcba) to solve the issue.As a secondary finding sp found log initialization error from the memory and found the 360 alarm lens cracked.To solve the secondary issues sp replaced line interface 2 pcba and 360 alarm lens.The unit passed all test and calibrations as per manufacturer specifications at the time of service.One ui pcba , line interface 2 pcba and the usb flash drive were received for failure analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.The cause of the observed issue is already linked to an existing corrective action.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15355453
• MDR Text Key: 305183411
• Report Number: 8020893-2022-00156
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: 10884521171541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/29/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/05/2022
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 8020893-03142022-01-C
• Patient Sequence Number: 1