MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX XTRAFLOW HME

Catalog Number	7291
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HME
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 6773223
• Report Number: 8032044-2017-00011
• Device Sequence Number: 14855188
• Product Code: BYD
• UDI-Device Identifier: 07331791005909
• UDI-Public: 7331791005909
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 7291
• Device Lot Number: 1702101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2017
• Device Age: 5 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1