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

Model Number	760
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr previously submitted under asr reporting.Device evaluation: the service engineer evaluated the ventilator and found the analog signal on the user interface section of controller printed circuit board out of range.The ventilator's proportional solenoid (psol) printed circuit board (pcb) was replaced to address the issue and returned for further analysis.The proportional solenoid pcb was returned for further product analysis.The reported condition was confirmed.Investigation isolated the fault to a faulty electronic component on the psol pcb, which was replaced.The ventilator then functioned normally.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of a pb760 ventilator entering a ventilator inoperable condition.The ventilator was not on a patient at the time of the event.
Additional Manufacturer Narrative
Device evaluation summary: a second 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 test ventilator for analysis.The ventilator powered onthe fi test-bed device failed post.The following alarm ¿low o2 supply¿ appeared on the display.The fault was isolated to component u31.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; michael collins rd mervue; galway
• MDR Report Key: 7425358
• Report Number: 8020893-2018-00179
• Device Sequence Number: 1052482
• Product Code: CBK
• UDI-Device Identifier: 10884521180932
• UDI-Public: 10884521180932
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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-760220DIUA-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1