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

Model Number	520A1299US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received in good condition.During initial testing, dut (device-under-test) cycled when child setting was selected.When selector switch was moved off of this position toward adult setting, it was noted that there was a constant flow of gas present: the reported issue was confirmed.Also, leak was noted at the nrv (non-return valve) filter and filter assembly, which was no longer in use.The root cause of the reported issue was deemed to be design-related.Action(s) taken to mitigate the reported issue(s): replaced nrv, variable restrictor, and piping; performed functional check and device cycled at all tidal volume settings.
Event or Problem Description
It was reported that the device did not do the breaths correctly on the adult setting - every six seconds, there was a constant blow of air.No patient injury was reported.

• Brand Name: PNEUPAC VRI STANDARD
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 440 kelley pkwy; minneapolis, MN 55442
• MDR Report Key: 15601104
• Report Number: 3012307300-2022-23933
• Device Sequence Number: 2200770
• Product Code: BTL
• UDI-Device Identifier: 10610586045721
• UDI-Public: 10610586045721
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: 520A1299US
• Device Catalogue Number: 520A1299US
• Device Lot Number: 1604121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown