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

Model Number	840
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the suspect device/component from the customer for evaluation.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 an 840 ventilator had a faulty battery.Although requested, information pertaining to the use of the device at the time of the reported event and patient outcome (if applicable) has not been provided.A non-medtronic/covidien service provider replaced the battery and power supply.Medtronic/covidien was not authorized to repair the device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received, the customer stated that a non-medtronic battery was used at the time of the reported event.There was no patient involvement at the time of the reported event.
Additional Manufacturer Narrative
A backup power source battery kit was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned components was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs.An investigation was performed and the product analysis technician reported that no fault was found.In addition, a non-medtronic battery was received.No investigation was performed as it is a non-medtronic part.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6755589
• Report Number: 8020893-2017-07222
• Device Sequence Number: 162672
• Product Code: CBK
• UDI-Device Identifier: 10884521077058
• UDI-Public: 10884521077058
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220DIEC-SP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/19/2017; 10/12/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 10/09/2017; 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1