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

Model Number	130003
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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 for evaluation, in good condition.No dirt or evidence of excessive wear were noted.Functional testing was performed.Oxygen concentration readings were found to be out of tolerance; the reported issue was confirmed.Expiratory time was found to be below specification, so calibration of the te needle was necessary.Also, when checking high pressure alarm with air mix, it was noted that the manometer needle did not rise to the selected 80 cmh2o and neither electronic nor pneumatic alarm sounded.This was unrelated to original complaint reason.The root cause of the reported issue was deemed to be that the flow block assembly was faulty most likely due to normal wear and tear.It was manufactured in 2006.Action(s) taken to mitigate the reported issue(s): replaced flow block with a new block; alarms activated as expected, device passed all functional tests.
Event or Problem Description
It was reported that the device oxygen level was below setting.No patient injury was reported.

• Brand Name: PNEUPAC
• 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; minneapolis, MN 55442
• MDR Report Key: 15606037
• Report Number: 3012307300-2022-24039
• Device Sequence Number: 16698122
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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 Model Number: 130003
• Device Catalogue Number: 130003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• 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: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2006
• 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