MAUDE Adverse Event Report: INTERSURGICAL UAB 22MM SINGLE HEATED WIRE BREATHING SYSTEM; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	2026035
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint sample is enroute and will be evaluated upon receipt.We will provide follow up report upon completion of our evaluation.There is no report of harm to patient.
Event or Problem Description
The a single limb heated circuit was used on a home care ventilator and alarmed.It was observed that the tubing had hole in it.There was no patient harm and the circuit was replaced.
Event or Problem Description
The a single limb heated circuit was used on a home care ventilator and alarmed.It was observed that the tubing had hole in it.There was no patient harm and the circuit was replaced.
Additional Manufacturer Narrative
The complaint sample is enroute and will be evaluated upon receipt.We will provide follow up report upon completion of our evaluation.There is no report of harm to patient.Based on complaint investigation information, an mdr review was completed to indicate the need to submit mdr# 1319447-2018-00005 and follow-up 1319447-2018-00005-001.A dhr review was completed for this lot and acceptance activities were completed with no nonconformities documented.The resistance of the heated wire was checked on the return sample and found to be in requirements.Investigation of the return sample was inconclusive.Damage to the system can be experienced with exposure to an external hot surface or covering or impeding of the heat flow.The instructions that accompany the device indicate "check that the coiled heated wire is not bunched inside the tube" and "do not cover the breathing system with anything that may insulate the air flow around the tube as this may impede normal heat transfer and cause damage to the system or affect gas delivery to the patient".

• Brand Name: 22MM SINGLE HEATED WIRE BREATHING SYSTEM
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): INTERSURGICAL UAB; arnioniu 60/28-1; pabrade, vilniaus apskritis lt-4710, lh ; LH
• MDR Report Key: 7728408
• Report Number: 1319447-2018-00005
• Device Sequence Number: 13815901
• Product Code: BZE
• UDI-Device Identifier: 05030267140343
• UDI-Public: 05030267140343
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: 092129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: No Information
• Device Model Number: 2026035
• Was Device Available for Evaluation?: Yes
• Device Age: 1 YR
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention