MAUDE Adverse Event Report: COVIDIEN 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	760
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the field service engineer evaluated the ventilator and replaced the pressure solenoid printed circuit board.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 during use on patient the 700 series ventilator has abnormal restart (inoperative).Patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.
Additional Manufacturer Narrative
Date should be (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the proportional solenoid (psol) printed circuit board (pcb) was returned for failure investigation.A visual inspection was carried out on the returned psol pcb, no anomalies were observed.The psol pcb was assembled into the failure investigation test ventilator for analysis.The ventilator powered on but failed at power on self test (post) for 'abnormal restart'.The fault was isolated to component u12.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7779095
• Report Number: 8020893-2018-00361
• Device Sequence Number: 1258245
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 760
• Device Catalogue Number: G-061949-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 10/16/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 08/13/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1