MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS BABYPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	510A1960NONEU
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several times while testing the device one continuous insulation breath when turning the knob.No patient injury was reported.
Additional Manufacturer Narrative
This 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.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection of unit showed no damage.The unit passed all tests.However when turned the switch forcibly to its end stop and held it there for a few seconds it did go into continuous flow, it did not repeat this every time performed this action but did go into continuous flow an average of one in every five turns when forcibly moved to the end stop.Removed the switch block from the unit module while it was sticking in the far position and giving the continuous flow removed the lid to see if any of the internal poppets had become stuck, they had not.The root cause of the reported issue was found to be the switch was not being used as intended.Actions were taken to mitigate the reported issue: the switch cam was changed.

• Brand Name: PNEUPAC VENTILATORS BABYPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15600778
• Report Number: 3012307300-2022-23910
• Device Sequence Number: 16713990
• Product Code: BTL
• UDI-Device Identifier: 15019517181173
• UDI-Public: 15019517181173
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Model Number: 510A1960NONEU
• Device Catalogue Number: 510A1960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2018
• 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