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

Model Number 840

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

At this time, medtronic has not received the suspect device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use, the 840 ventilator suddenly alarmed and the device stopped operation; it was reported that the ventilator went into a safety valve open condition.The patient was transferred to another ventilator.The patient was noted to be able to breath by themselves and there was no harm to the patient as a result of the event.The customer reported that they found an issue with the power supply.

Manufacturer Narrative

Device evaluation: a service engineer (se) inspected the device and found that the power supply was faulty and needed replacement.The customer requested that the unit be returned to the hospital unrepaired as the customer was to use another ventilator unit instead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: information was received on (b)(4) 2018 that the date that the evaluation was performed was (b)(4) 2018.Corrected return date.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7553187
• MDR Text Key: 109530129
• Report Number: 8020893-2018-00244
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: 10884521076891
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

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
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840120DIJJ-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 08/27/2018; 12/24/2018
• Supplement Dates FDA Received: 12/21/2018; 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1