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 Code	Low Oxygen Saturation (2477)
Date of Event	05/23/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Service device evaluation summary: the service engineer (se) inspected the device at the customer¿s site, reviewed the logs but was unable to confirm a malfunction on the device.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was involved in a motor vehicle accident (mva).The date of the mva was not specified.While the 980 ventilator was in use on the patient, the patient¿s spo2 (saturation of peripheral oxygen) dropped between 40 ¿ 50 percent.Reportedly, there were two events, the first occurring on (b)(6) 2018 in which the patient desaturated to 40 percent and the specialist anesthetist indicated that the ventilator malfunctioned and suggested to change out the ventilator.However, the suggestion was ¿dropped¿ and the team carried out the necessary treatment and increased the fio2 (fraction of inspired oxygen) to 100 percent.The patient was reported to have stabilized.The second event occurred on (b)(6) 2018 in which the patient desaturated to 40 percent.The patient was removed from the ventilator and placed on an alternate ventilator (non-medtronic device, e-vent).The response from the customer was that the patient did ¿not really¿ stabilize after that event.On (b)(6) 2018 the patient passed away.The patient¿s medical history was described as being involved in a motor vehicle accident and the cause of death attributed to ards (acute respiratory distress syndrome).Although there is no indication that a malfunction of the pb 980 ventilator occurred, this event is being conservatively reported due to the death of the patient.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 7634550
• Report Number: 8020893-2018-00284
• Device Sequence Number: 10814232
• Product Code: CBK
• UDI-Device Identifier: 10884521201910
• UDI-Public: 10884521201910
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980A3ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/25/2018
• 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: Death