MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX XTRAFLOW HME

Catalog Number 7291

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aspiration/Inhalation (1725)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

This is an initial report.Investigation: xtraflow ref 7291, lot number 1702101.Since no product was returned from the customer it is not possible to determine if the hme had any errors.It is therefore only a theoretical investigation and following failure modes that can be connected to (b)(4) have been found in (b)(4): -product is obstructed with mucus.-lid stuck in closed position.If the hme lid is stuck in bottom position or mucus is blocking the hme the user will normally remove the hme from adhesive.Conclusion/action: no malfunctions have been found.

Event Description

This is the information that was received from the atos medical local representative: sister (b)(4) called to inform atos, that one of the hme of lot # 1702101 when inserted caused the patient not able to breath, they removed it and he was able to catch his breath.Patient is still using the other hme from the same lot and is working just fine.

• Brand Name: PROVOX XTRAFLOW HME
• Type of Device: HME
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• Manufacturer (Section G): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• Manufacturer Contact: karolina nilsson ; kraftgatan 8; horby, SE-24-222 ; SW SE-24222
• MDR Report Key: 6773223
• MDR Text Key: 83237271
• Report Number: 8032044-2017-00011
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 07331791005909
• UDI-Public: 7331791005909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 7291
• Device Lot Number: 1702101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2017
• Device Age: 5 MO
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1