MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS PARAPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 120003

Device Problem Failure to Cycle (1142)

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

Event Type  malfunction  

Manufacturer Narrative

No information has been provided to date.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 vent will intermittently not cycle while connected to oxygen.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.The reported fault suggests the 15 year old device did malfunction.Without the device being returned for analysis, it is not possible to determine whether this was due to wear and tear or impact damage.Intermittent cycling was also reported in july 2021 and preventive measures were taken so it is unlikely that the reported problem is due to the previous repair.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: PNEUPAC VENTILATORS PARAPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; attn:receiving; minneapolis, MN 55442
• MDR Report Key: 15742713
• MDR Text Key: 306811090
• Report Number: 3012307300-2022-26813
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020899
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1