MAUDE Adverse Event Report: COVIDIEN HT70 PLUS VENTILATOR; CONTINUOUS VENTILATOR

Model Number HT70

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Respiratory Failure (2484)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The evaluation and repair of the ventilator has not been done yet.

Event Description

It was reported that during patient use the ventilator stopped functioning completely and turned off.The patient turned cyanotic and was transferred to a different ventilator.Patient diagnosis: repertory failure stroke.

Manufacturer Narrative

(b)(4).The ventilator was returned for evaluation, however, the alleged malfunction could not be confirmed.

Manufacturer Narrative

An investigation was performed and the technician found that the reported problem could not be duplicated.No failure was detected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HT70 PLUS VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer (Section G): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6105049
• MDR Text Key: 59971784
• Report Number: 8020893-2016-03108
• Device Sequence Number: 1
• Product Code: CBK
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided; 12/13/2016
• Supplement Dates FDA Received: 12/26/2016; 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 90 YR