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

Model Number	980
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Tissue Damage (2104); High Oxygen Saturation (2478)
Date of Event	02/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.The customer has refused return of the ventilator or an evaluation to take place.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during use on a neonatal patient, the actual pip (peak inspiratory pressure) measurement on a 980 ventilator was more than the settings.According to the attending physician, the delivery of the high pressure resulted in patient injury (barotrauma).Reportedly, a chest tube was inserted into the patient to remove the excessive air.The patient was removed from the ventilator and placed on an alternate ventilator.
Additional Manufacturer Narrative
Correction to section: catalog number, serial number and unique identifier number.Correction to section: manufacture date.The serial number was confirmed by the distributor.Additional information received as follows: per the distributor, the device was used by the respiratory therapists and physicians without attending training on the neonate mode.The distributor reported to medtronic that they have assumed all training for their customers.Per distributor, the ventilator was evaluated and testing performed.All testing passed per specifications and was released as safe.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: 7334902
• Report Number: 8020893-2018-00129
• Device Sequence Number: 16310893
• Product Code: CBK
• UDI-Device Identifier: 10884521201385
• UDI-Public: 10884521201385
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 11/19/2018

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
• Operator of Device: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980A3ENNISB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention