MAUDE Adverse Event Report: HALYARD HEALTH BALLARD 1500 HME; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES

Model Number 153

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

No known impact or consequence to patient.Device operates differently than expected.(b)(4).Upon completion of the investigation; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

It was reported that the heat moisturizer exchange became saturated with moisture within 12 hours of use."the saturated heat moisturizer exchange caused the ventilator "occlusion alarm" to sound.The heat moisturizer exchange was replaced with a new one and the "occlusion alarm" stopped".No reported patient injury.

Manufacturer Narrative

The device history record for the reported lot number, 2014-12-04, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.One sample device was returned.The original packaging was not returned with the device.The product did not contain a lot number identification.The sample was visually inspected.There was no visible defects or occlusions.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).

• Brand Name: BALLARD 1500 HME
• Type of Device: VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AB ULAX; merkuriusgatan 8; motala ostergotlands lan [se-05],; sweden GA 59132 ; SW 59132
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 4946886
• MDR Text Key: 23117987
• Report Number: 3011270181-2015-00012
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/08/2015

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
• Device Operator: Other Health Care Professional
• Device Model Number: 153
• Device Catalogue Number: 991093819
• Device Lot Number: 2014-12-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1