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

Model Number	760
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the service engineer evaluated the device and replaced the pressure solenoid (psol)printed circuit board (pcb).The ventilator passed all testing and was placed back in clinical use.The psol pcb was returned for failure investigation.A visual inspection was carried out on the returned psol pcb, no anomalies were observed.The part was assembled in the failure investigation test ventilator.The ventilator was powered on and failed the post(power on self test).The fault was isolated to a u31 component on the psol pcb.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 760 ventilator had post failed.The device was replaced.No patient harm reported.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7661179
• Report Number: 8020893-2018-00299
• Device Sequence Number: 14110667
• Product Code: CBK
• UDI-Device Identifier: 10884521180918
• UDI-Public: 10884521180918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990897
• 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
• Report Date (Section B): 07/03/2018

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-760110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1