MAUDE Adverse Event Report: NULL PNEUPAC VENTILATORS VR1 STANDARD; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number 520A1125

Device Problem No Flow (2991)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event and udi number are unknown, g5: 510k is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the ventilator had a system failure.There has been no report of patient involvement.

Event Description

Additional information received on 18-jul-2023 via email.The event occurred on mar-2023 during testing, before patient was hooked up.No medical intervention required.No injury reported.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Clinical signs and health impact updated.

• Brand Name: PNEUPAC VENTILATORS VR1 STANDARD
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 16693663
• MDR Text Key: 313523558
• Report Number: 3012307300-2023-03693
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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 Catalogue Number: 520A1125
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1