MAUDE Adverse Event Report: NULL PNEUPAC VENTILATORS; BREATHING CIRCUIT CIRCULATOR

Catalog Number 520A1125

Device Problem Output Problem (3005)

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

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that the rescue crew reported that when in automatic mode the ventilations become more prolonged.

Manufacturer Narrative

H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device was in good condition.The customer stated problem was duplicated, continuous flow is present and intermittent at detent and adult settings.Replaced faulty timing valve assembly.During investigation was found wear and tear on 15 year old device that probably suffered impact damage (yellow case separation was found).The cause of the reported problem could not be determined.The previous service history has been reviewed and deemed unrelated to the current customer reported reason.

Event Description

Per ro 1203042: the rescue crew reported that when in automatic mode the ventilations become more prolonged.Additional information received via email on 03-jan-2022: date of event updated, ".It was with a patient and was noticed right away, where the crew disconnected and switched to manual ventilations via bvm.It was also rechecked after the call and happened again when not connected to a patient.No adverse effects were noted in the report.".

• Brand Name: PNEUPAC VENTILATORS
• Type of Device: BREATHING CIRCUIT CIRCULATOR
• Manufacturer (Section G): NULL
• MDR Report Key: 13193202
• MDR Text Key: 283942748
• Report Number: 3012307300-2022-00294
• Device Sequence Number: 1
• Product Code: CAG
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

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 Catalogue Number: 520A1125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 03/04/2022; 06/14/2023
• Supplement Dates FDA Received: 03/28/2022; 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention