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

Model Number	G-760220DIUA-EN
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported by the (b)(6) fda.It was reported that the hospital staff (engineer) inspected the unit.The engineer confirmed the reported issue and found that the printed circuit board (pcb) was faulty.If information is provided in the future, a supplemental report will be issued.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, this 760 ventilator was generating a warning message but there was no alarm sound.The patient was removed from the ventilator and placed on an alternate ventilator without harm.

• Brand Name: PURITAN BENNETT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11619603
• Report Number: 8020893-2021-00050
• Device Sequence Number: 17118211
• Product Code: CBK
• UDI-Device Identifier: 10884521180932
• UDI-Public: 10884521180932
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: G-760220DIUA-EN
• Device Catalogue Number: G-760220DIUA-EN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR