MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); No Information (3190)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) evaluated the ventilator and found a gui (graphic user interface) reset error code logged once.The ventilator has passed calibrations, electrical safety, extended self test (est), and short self test (sst) per manufacturer's specification and was released to the customer for clinical use.The report of a blank gui display and code identified (gui reset) in the ventilator log indicates that the ventilator did not stopped ventilating the patient.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use the 840 ventilator display was blank and the ventilator "got turned off".The patient was removed from the ventilator and placed on an alternate ventilator.The patient's blood pressure and oxygen saturation dropped as a result of the reported event.Multiple attempts have been made to obtain additional information on the patient outcome, treatment (if applicable) and clarification of the event; however, no additional information was able to be obtained.The report of a blank gui display and code identified (gui reset) in the ventilator log indicates that the ventilator did not stopped ventilating the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received as follows: the ventilator made a loud noise described as a ¿bang¿and stopped ventilating a chemically paralyzed patient.The patient¿s base line blood pressure before the reported event was (b)(4).The blood pressure dropped to (b)(4) during the event but returned to 104/58.The patient's base line oxygen saturation before the reported event was 94%.The saturation level dropped to 89% during the event but returned to 98%.There was no short term or long term impact to the patient related to the reported event.Additionally it was reported that care was withdrawn from the patient and the patient expired on (b)(4) 2018, which was not related the the reported event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7793978
• Report Number: 8020893-2018-00374
• Device Sequence Number: 1293217
• Product Code: CBK
• UDI-Device Identifier: 10884521076877
• UDI-Public: 10884521076877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151252
• 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): 09/10/2018

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: 840
• Device Catalogue Number: 4-840120DICU-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 60