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

Model Number	760
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer evaluated the ventilator and replaced eprom's (erasable programmable read-only memory) and air intake manifold assembly.After servicing, the ventilator passed all testing per manufacturer's specification and was returned to the customer.The eprom's and air intake manifold assembly was visually inspected with no anomalies observed.The components were connected to a test ventilator.The ventilator failed the power on self test.The fault was isolated to a component on the eprom.There was no malfunction or product deficiency identified on the returned air intake manifold assembly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 760 ventilator had failed post (power on self test) and additionally est (extended self test) failure occurred because of faulty air intake assembly.The ventilator was not in use on a patient at the time of the reported event. .

• Brand Name: 760 VENTIALTOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 8192056
• Report Number: 8020893-2018-00579
• Device Sequence Number: 11423230
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 12/21/2018

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: 12/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1