MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES

Model Number 150

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 13-nov-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Avanos medical, inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the third of four reports.Refer to 3011270181-2019-00062 for the first event.Refer to 3011270181-2019-00063 for the second event.Refer to 3011270181-2019-00065 for the fourth event.It was reported the heat moisture exchange (mhe) was not fitting on the circuit with a tight fit.Additional information received 22-nov-2019 stated the event usually occurs between 2-hours and 6-hours during use.The vent alarm sounds when this occurs.The hme connection is simply reconnected to closed suction system (css) or changed out.

Manufacturer Narrative

The device history record for the reported lot number in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 06-mar-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER
• Type of Device: VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9324394
• MDR Text Key: 177578424
• Report Number: 3011270181-2019-00064
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 150
• Device Catalogue Number: 109381603
• Device Lot Number: 2018-11-202019-04-15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2020
• Patient Sequence Number: 1
• Treatment: HUDSON RCI