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

Model Number 4096600-04

Device Problem Defective Alarm (1014)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: complaint was reported by a medtronic service personnel on behalf of the facility.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.Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during servicing, this pb560 ventilator did not generate a patient disconnection alarm in pediatric mode.The service personnel (sp) inspected the ventilator and could not duplicate the reported issue.The ventilator passed all tests and calibrations per manufacturer specifications and was returned to the customer.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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during servicing, this pb560 ventilator did not generate a patient disconnection alarm in pediatric mode.The ventilator was not in use on a patient at the time of the reported event.

• 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: 14311602
• MDR Text Key: 290960024
• Report Number: 8020893-2022-00078
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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
• Report Date: 05/05/2022

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: 4096600-04
• Device Catalogue Number: 4096600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• 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