MAUDE Adverse Event Report: COVIDIEN HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70
Medical Device Problem Codes	Device Alarm System (1012); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the ventilator was received by medtronic and an investigation was performed.When the unit was powered up and it completed the power on self-test (post), the alarm silence light emitting diode (led) illuminated.The cancel and down arrows were found to be unresponsive.When the unit was powered down, the shutdown alarmed immediately silenced.The top membrane was replaced with a known good top membrane.When the unit was powered up, the down and cancel button functioned properly.When the unit was powered down, the shutdown alarm did not silence until the alarm silence/reset button was pressed.Upon further investigation of the top membrane, the cause of the event was indicated to be a short between two pins of the top membrane.All three membranes were replaced along with the associated overlays to resolve the issue.The latest software was installed.Since the correct ventilator working hours could not be tracked, the pump was replaced.The ventilator was pending preventative maintenance only.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ht70 ventilator down arrow was not responding and that the audible alarms were not sounding properly.The alarm was reported to sound but was "incomplete it sputtered".The ventilator was not in use on a patient at the time of the event.During evaluation, the ht70 ventilator failed to alarm on shutdown.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8854914
• Report Number: 2023050-2019-00031
• Device Sequence Number: 2499040
• Product Code: CBK
• UDI-Device Identifier: 10884521542143
• UDI-Public: 10884521542143
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: HT70M-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1