MAUDE Adverse Event Report: VYAIRE MEDICAL 10PK, DUAL,HTD CKT,SPU, PEDPEEPLESS; HEATED AND NON-HEATED BREATHING CIRCUITS

Model Number 10PK, DUAL,HTD CKT,SPU, PEDPEEPLESS

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the exhalation valve tubing is too short to be able to move around.The customer that they either have to take the patient off the vent to empty out tubing or it will drain onto the electronic devices.There was no patient harm associated with the reported event.

• Brand Name: 10PK, DUAL,HTD CKT,SPU, PEDPEEPLESS
• Type of Device: HEATED AND NON-HEATED BREATHING CIRCUITS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la producci?n; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, il ; 3273284
• MDR Report Key: 10474837
• MDR Text Key: 205725071
• Report Number: 8030673-2020-00117
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10PK, DUAL,HTD CKT,SPU, PEDPEEPLESS
• Device Catalogue Number: 15091-104
• Device Lot Number: 0004067819
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1