MAUDE Adverse Event Report: COVIDIEN PB560 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 4096600-02

Device Problems Defective Alarm (1014); Pressure Problem (3012)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

Section a and e: patient and initial reporter's information cannot be provided due to japan privacy regulation.Section g: there is no 510k associated to this device.The device associated with this event is an authorized product under the emergency use authorization (eua) issued by fda for the covid-19 pandemic.This device was granted by fda on april 05, 2020.H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this pb560 ventilator displayed a low pressure but the alarm sound did not ring.The device was available for evaluation.The service personnel (sp) inspected the unit but could not confirm or reproduce the reported issue.As a secondary finding, the sp found that the flow sensor was not clean.As a precaution, the central processing unit (cpu) including the flow sensor will be replaced.The investigation could not confirm the reported issue but found dirty flow sensor as secondary issue, a cause to the reported issue was not determined.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.

Event Description

It was reported that while in use on a patient, this pb560 ventilator displayed a low pressure but the alarm sound did not ring. the patient was removed from the ventilator and placed on an alternate ventilator without injury.

Manufacturer Narrative

Updated section b5 updated section h6 device codes - removed a160106 added a1411 evaluation code result - removed c13 and added c19 component code removed g07001 and added g07003.There is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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.

Event Description

It was reported that while in use on a patient, this pb560 ventilator displayed a low pressure but the alarm sound did not ring. the patient was removed from the ventilator and placed on an alternate ventilator without injury.Based on the logs provided, it was identified that there was no evidence to suggest the alarm banner nor alarm audio is not working properly.

Manufacturer Narrative

Section d9 updated due to part return.Section h6 evaluation code result remove c19 and add c13.H3: device evaluation summary: updated due to part return.Medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this pb560 ventilator displayed a low pressure but the alarm sound did not ring.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not reproduce or confirm the reported issue.As secondary findings, sp found that re- calibration of the inspiration flow sensor was required in a short period of time, so the cpu printed circuit board (pcb) was replaced and also replaced the turbine and the inspiratory block due to excessive dirt.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The replaced turbine and inspiratory block were not received for analysis.One cpu pcb was received for failure analysis.A visual inspection was carried out on the returned component, no anomalies were observed.The cpu pcb was attached to the failure investigation test ventilator for analysis.The ventilator failed the ¿int valve pressure¿ sensor calibration.The fault was isolated to the faulty cpu pcb.The investigation could not confirm or determine a cause of the reported issue but as a secondary finding found an issue with the cpu pcb.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a trending and monitoring plan.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: PB560 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: 17191959
• MDR Text Key: 318137333
• Report Number: 8020893-2023-00387
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2024

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: 4096600-02
• Device Catalogue Number: 4096600-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 07/03/2023; 01/19/2024
• Supplement Dates FDA Received: 07/24/2023; 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1