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

Model Number	520A1299US
Medical Device Problem Codes	Leak/Splash (1354); Device Fell (4014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a customer dropped a smiths medical ventilator and it's leaking internally.No patient involvement.
Additional Manufacturer Narrative
H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device intact but dirty.The customer stated problem was duplicated, when back pressure is applied, device leaked pressure internally.It was found a faulty oscillator (stuck or jammed), device not functionally properly.Replaced faulty oscillator, faulty regulator, faulty demand valve, faulty amsv assembly.Replaced vr1 housing upper, language specific gas label and serial number label.Upgraded non return valve and variable restrictor.Installed service kit 520a1146 and patient valve assembly as part of pm.Performed pm, calibrated, cleaned unit and affixed new service label.The cause of the reported problem was traced to: user damaged the device by dropping it.No previous service history.Manufacturing dhr is not relevant to the investigation due to the age of the device.

• 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): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11290172
• Report Number: 3012307300-2021-00951
• Device Sequence Number: 14312694
• Product Code: BTL
• UDI-Device Identifier: 10610586045721
• UDI-Public: 10610586045721
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 520A1299US
• Device Catalogue Number: 520A1299US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• 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: 01/06/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2012
• 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