MAUDE Adverse Event Report: VYAIRE MEDICAL PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 19260-001

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned and evaluation is anticipated, but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that their revel ventilator showed high amounts of vte and then goes down to 0, no lung issues with patient and no alarm.Patient was not affected and placed on another vent for transport however no harm was noted.

Manufacturer Narrative

H10: service technician was not able to duplicate customer's reported problem "vent having high amounts of vte's and then goes down to 0." vent was tested with a known good ac adapter and known good patient circuit connected.Vent passed 165 hour extended tests at customer's settings.Vent passed initial final test and initial alarm volume test, which include alarm and ventilation functions.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9881187
• MDR Text Key: 185137955
• Report Number: 2031702-2020-03431
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029
• Combination Product (y/n): N
• PMA/PMN Number: K070594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 19260-001
• Device Catalogue Number: 19260-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention