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

Model Number	980
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device and replaced the universal serial bus (usb).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced part is returned for failure investigation, a supplement medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, a 980 ventilator entered into backup ventilation.The patient was removed from the ventilator and placed on an alternate ventilator.The patient desaturated.
Additional Manufacturer Narrative
Device evaluation summary: the service personnel (sp) reported that the backup ventilation (buv) was confirmed and the customer requested to change the equipment.Sp reported that medtronic (b)(4) is conducting business procedures for this.Also an alert code (unable read the expiratory flow sensor) was recorded as a secondary issue.Sp adjusted and calibrated the flow sensor to address the secondary issue.By recommendation of the factory, the change of the universal serial bus(usb) was also performed.The cause of the reported event could not be established.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 7848520
• Report Number: 8020893-2018-00420
• Device Sequence Number: 1986638
• Product Code: CBK
• UDI-Device Identifier: 10884521201224
• UDI-Public: 10884521201224
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980S1ESDIUA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 70