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

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a service engineer (se) inspected the device and found the reported error in the logs.The se replaced the inspiratory module printed circuit board (pcb) to resolve the reported issue.During testing, the unit was found to not pass oxygen sensor calibration.The se replaced the oxygen sensor.The unit passed testing and operated within the manufacturing specifications.Should the replaced components be returned to the manufacturing site, an additional evaluation will be performed and a supplemental report will be submitted.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, the 840 ventilator alarmed and generated an error code which rendered the unit inoperable.The patient was placed on an alternate ventilator and there was no harm to the patient as a result of the event.
Additional Manufacturer Narrative
Device evaluation summary: both the inspiratory module printed circuit board and the oxygen sensor were returned for failure investigation.The investigation is in progress for the inspiratory module and a follow up medwatch report will be submitted once the investigation is complete.The oxygen (o2) sensor was returned for failure investigation.It was noted that the manufacturing date was (b)(6) 2014.A visual inspection of the returned part showed no anomalies.The 02 sensor was installed into a failure investigation test ventilator for analysis.During o2 sensor calibration a low urgency alarm indicated that the o2 senor failed to calibrate.A reading taken with a fluke meter on the sensor read 2.1 mv.The acceptable pass range is between 8.5 mv and 13.5 mv.The ventilator's oxygen sensor has a nominal life of 1 year.Since the o2 sensor has a nominal life of one year, this part exceeds this useful life.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the inspiratory printed circuit board was returned for failure investigation.The part was visually inspected and functionally tested with no anomalies observed.Conclusion: no fault found.There was no malfunction or product deficiency identified.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: 7940491
• Report Number: 8020893-2018-00490
• Device Sequence Number: 19025242
• Product Code: CBK
• UDI-Device Identifier: 10884521076877
• UDI-Public: 10884521076877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/15/2018

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: 4-840120DICU-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 11/13/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1