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

Model Number	G-760220DIUA-EN
Medical Device Problem Code	Pre Or Post-Pumping Problem (1477)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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 a post past failure.Patient involvement is unknown.
Additional Manufacturer Narrative
The initial submission was sent inadvertently.This product falls under asr exemption reporting.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PURITAN BENNETT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA; costa mesa
• MDR Report Key: 6596271
• Report Number: 2023050-2017-05338
• Device Sequence Number: 979755
• Product Code: CBK
• UDI-Device Identifier: 10884521180932
• UDI-Public: 10884521180932
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G-760220DIUA-EN
• Device Catalogue Number: G-760220DIUA-EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided; 06/08/2017
• Initial Report FDA Received Date: 05/27/2017
• Supplement Report FDA Received Date: 06/08/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1