MAUDE Adverse Event Report: PNEUPAC; POWERED EMERGENCY VENTILATOR

Model Number P310NUS

Device Problem Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

Event Type  malfunction  

Event Description

It was reported that the device produces constant pressure on the patient.

Manufacturer Narrative

Device was received in with hairline cracks along the top case and other damage.The device was then connected to an o2 source where it was found that the customer complaint was confirmed.Probable cause of issue is traced to impact damage., corrected data: event date: (b)(6) 2021.No patient injury reported.

• Brand Name: PNEUPAC
• Type of Device: POWERED EMERGENCY VENTILATOR
• MDR Report Key: 12309149
• MDR Text Key: 266078840
• Report Number: 3012307300-2021-08317
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: 35019315107263
• Combination Product (y/n): N
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1