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

Model Number 120003

Device Problem Medical Gas Supply Problem (2985)

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

Event Type  malfunction  

Event Description

It was reported the device does not mix air and o2 properly.No patient injury was reported.

Event Description

Additional information was received that stated the issue was found during inspection.

Manufacturer Narrative

Other text: the device was returned with loose patient outlet.Functional checks were performed.The o-ring was out of place; it did not sit in the groove as it should.Applied fomblin and installed a new o-ring on the poppet seat.The manometer was also replaced as a preventative measure.Additional repairs were completed due to wear and tear and impact damage.(h6c, h6d, h6e).D5 and e4 are unknown.No previous service history was found.The manufacturing device history record is not relevant to the investigation due to the age of the device.

• Brand Name: PNEUPAC VENTILATORS
• 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; minneapolis, MN 55442
• MDR Report Key: 14757288
• MDR Text Key: 302012784
• Report Number: 3012307300-2022-12283
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1