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

Model Number	760
Medical Device Problem Code	No Display/Image (1183)
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 customer reported the ventilator's proportional solenoid (psol) printed circuit board (pcb) was replaced to address the issue and returned for further analysis.The reported condition was not confirmed in the field.The proportional solenoid pcb was returned for further product analysis.The reported condition was confirmed.When installed into a test ventilator, the ventilator's display was blank upon startup.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
It was reported that the pb760 ventilator's display did not operate upon startup except for the alarm indicator light.There was no patient involvement at the time of the reported event.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins rd mervue; galway
• MDR Report Key: 7423011
• Report Number: 8020893-2018-00177
• Device Sequence Number: 13464925
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 03/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1