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

Model Number HT70

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the service engineer evaluated the device and reconnected the alarm cable to the single board computer assembly.After reconnecting the cable, the ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, during use on patient, the ht70 ventilator did not generated an audio alarm when the patient circuit was disconnected to use the nebulizer.The patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.

• Brand Name: HT70 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins rd mervue; galway,ie
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway,ie
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 8515986
• MDR Text Key: 141987352
• Report Number: 8020893-2019-00086
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542266
• UDI-Public: 10884521542266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT70
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Date Manufacturer Received: 03/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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
• Patient Age: 80 YR
• Patient Weight: 81