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

Model Number	VR1
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: one pneupac ventilators (vr1 standard) was returned for investigation in used condition.There was no physical damage on the device.The investigator subjected the device to testing.In auto or manual modes, the investigator could not the tidal volume to vary.The device did not cycle according to the frequency setting.It was producing a constant flow instead.The customer reported product problem was therefore confirmed.The problem source of the reported product problem was unknown.A root cause was not established.The investigator upgraded the nrv to the current revision.The variable restrictor was also upgraded.The upper housing was replaced.Preventative maintenance was then performed.The device subsequently passed all the functional tests.
Event or Problem Description
It was reported the unit was not functioning properly.When in auto mode, it did not stop blowing air.When in manual mode, and the button was pressed, the unit did not stop blowing when the tidal volume was reached.The device did not produce any alarms.The product problem was observed on (b)(6) 2019.There was no patient involvement.The problem was observed during testing.The customer noted that the ventilator was not serviced since it was originally purchased.

• Brand Name: PNEUPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 10098380
• Report Number: 3012307300-2020-05300
• Device Sequence Number: 3406901
• Product Code: BTL
• UDI-Device Identifier: 10610586045721
• UDI-Public: 10610586045721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: No Information
• Device Model Number: VR1
• Device Catalogue Number: 520A1299US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 05/28/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2015
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1