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

Model Number	980X3ENDIUU-RMF
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation device summary: medtronic conducted an investigation based upon all information received.It was reported that during use on a patient, this 980 ventilator stopped ventilation.The device was available for evaluation.It was reported that, during use on a patient, this 980 ventilator stopped ventilation.A review of the ventilator diagnostic logs showed that the there was a loss of ventilation at the time of the event.The service personnel (sp) inspected the ventilator and found relevant diagnostic codes in the ventilator memory logs.The sp replaced the breath delivery unit (bdu) power supply.The ventilator passed all required tests and calibrations per manufacturing specifications at the time of service and was returned to the customer.The likely cause of the event was isolated in the field to a potential fault in the bdu power supply.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during use on a patient, this 980 ventilator stopped ventilation.Patient was removed from the ventilator and placed on an alternate ventilator with no injury reported.
Additional Manufacturer Narrative
Correction: h3 device evaluation summary: updated due to component return: medtronic conducted an investigation based upon all information received.It was reported that during use on a patient, this 980 ventilator stopped ventilation.The device was available for evaluation.It was reported that, during use on a patient, this 980 ventilator stopped ventilation.A review of the ventilator diagnostic logs showed that the there was a loss of ventilation at the time of the event.The service personnel (sp) inspected the ventilator and found relevant diagnostic codes in the ventilator memory logs.The sp replaced the breath delivery unit (bdu) power supply.The ventilator passed all required tests and calibrations per manufacturing specifications at the time of service and was returned to the customer.The replaced bdu (breath delivery unit) power supply was returned for further analysis: the returned bdu (breath delivery unit) power supply was visually inspected and functionally tested with no malfunction or product deficiency observed.The replaced bdu (breath delivery unit) power supply did resolve the issue in the field; however, the returned component was analyzed and was testing satisfactorily.With the information available a likely cause could not be determined.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.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: PURITAN BENNETT
• Common Device Name: 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: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 12467253
• Report Number: 8020893-2021-00139
• Device Sequence Number: 17092390
• Product Code: CBK
• UDI-Device Identifier: 10884521592926
• UDI-Public: 10884521592926
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: 980X3ENDIUU-RMF
• Device Catalogue Number: 980X3ENDIUU-RMF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown