MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number PB980

Device Problem No Flow (2991)

Patient Problem Injury (2348)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Event was received from the food and drug administration (fda) under mw508901 additional information was requested from the fda (food and drug administration).Fda stated, ¿the report that was sent is the copy that provides you with all the allowed releasable information from the report.Unfortunately, we are unable to release any further information that pertains to the report in question." the ventilator product number and serial number were not provided.Additionally, the facility and reporting person were not provided.Therefore, medtronic is unable to further assess this event due to incomplete information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via a medwatch report (mw5089013), that while in use on a patient, a 980 ventilator ¿stopped ventilating patient, ventilator did not self activate audible alarms as device is set up to do¿.The report indicates ¿serious injury as the event report type¿ and an ¿event outcome of life threatening¿.Additional information was requested from the fda (food and drug administration).A response from the fda stated, ¿the report that was sent is the copy that provides you with all the allowed releasable information from the report.Unfortunately, we are unable to release any further information that pertains to the report in question.Reporters may elect to not be identified to the device manufacturer, which could explain why fields that may identify the reporter are not included in the copy that was sent.¿.

• Brand Name: 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 9162641
• MDR Text Key: 162661402
• Report Number: 8020893-2019-00197
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB980
• Device Catalogue Number: PB980
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening