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

Model Number 4096600-02

Device Problem Defective Alarm (1014)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter information and patient identifier information cannot be provided due to the restriction by the (b)(6) privacy regulation.Medtronic affiliate reported on behalf of the customer.There is no 510k number associated with 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 authorization by fda on (b)(6) 2020.Medtronic received the suspect device/component from the customer, but the device has not yet been evaluated to date.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 pb560 ventilator did not alarm when the fraction of inspired oxygen (fio2) value was over the set value.There was no reported patient injury.Although requested, patient intervention was unknown at this time.

Manufacturer Narrative

Correction to section h6 evaluation code method, result, and conclusion codes.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient the pb560 ventilator did not alarm when the fraction of inspired oxygen (fio2) value was over the set value.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not confirm the reported issue.The sp performed preventive maintenance (pm).The ventilator passed all tests and calibrations per manufacturer specifications at the time of service.The investigation found the device to function normally as expected.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.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

Additional information received as follows: the patient was transferred to an alternate ventilator without injury.

Manufacturer Narrative

Additional information received: 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: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 14254593
• MDR Text Key: 290460125
• Report Number: 8020893-2022-00075
• 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: 06/27/2022

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
• 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: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/02/2022; 06/23/2022
• Supplement Dates FDA Received: 05/27/2022; 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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
• Patient Sex: Male