MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service engineer (se) inspected the device and found that battery back up was damaged.The repairs have not yet been completed at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use, 840 ventilator lacked patient ventilation and did not provide volume.At this time, it is unknown if the patient was transferred to an alternate ventilator or if there was patient harm.
Additional Manufacturer Narrative
Device evaluation summary: the field service engineer evaluated the ventilator and found a damaged battery backup.The customer has not authorized repair at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received as follows: the ventilator was no in use on a patient at the time of the reported event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7811681
• Report Number: 8020893-2018-00395
• Device Sequence Number: 16511197
• Product Code: CBK
• UDI-Device Identifier: 10884521077096
• UDI-Public: 10884521077096
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 840
• Device Catalogue Number: 4-840220DIPC-PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1