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

Model Number 4096600-01

Device Problem Defective Alarm (1014)

Patient Problem Hypoxia (1918)

Event Date 08/06/2022

Event Type  Injury  

Manufacturer Narrative

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 april 5, 2020.H3 - medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.Additional details and ventilator logs have been requested 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, the control line to the exhalation valve on a single limb circuit of this pb560 ventilator was kinked and the ventilator did not generate an alarm.The ventilated patient became unconscious and the oxygen saturation dropped to 62% for approximately 2 minutes.The ventilator continued to be used as the crease/kink in the hose was detected and corrected by a caregiver.

Manufacturer Narrative

H3 device evaluation: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the control line to the exhalation valve on a single limb circuit of this pb560 ventilator was kinked and the ventilator did not generate an alarm.The caregiver, of patient, detected and corrected the crease/kink in the hose and continued to use the ventilator.The device was evaluated by medtronic local support personnel (distributor) after the event and there was no fault found.Additionally, the device¿s logs were reviewed by the subject matter experts who observed the unit had numerous alarms at different times on the event date and there were no logs indicating that there was an issue with the alarm.With the information available, the investigation found the device to function normally.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: 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: 15407264
• MDR Text Key: 299771954
• Report Number: 8020893-2022-00162
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4096600-01
• Device Catalogue Number: 4096600-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male