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

Model Number	VENTILATOR MEDIC PARAPAC
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	Asthma (1726); Respiratory Distress (2045)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information received a smiths medical ventilators|pneupac ventilators|pneupac disposable circuits mask seal was not inflated sufficiently and completely flat.A patient with asthma was needing the cpap and it was impossible to create a good seal for the device to work efficiently.In order to support care and airway control, the patient required bag valve mask airway control due to circuit mask not able to be implemented.No loss of airway control, as bag valve mask was efficient for the interim.This was a interruption in airway control.

• Brand Name: VENTILATORS PNEUPAC VENTILATORS PARAPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9951841
• Report Number: 3012307300-2020-02942
• Device Sequence Number: 2728376
• Product Code: BTL
• UDI-Device Identifier: 15019315079214
• UDI-Public: 15019315079214
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: VENTILATOR MEDIC PARAPAC
• Device Catalogue Number: 100/905/361
• Device Lot Number: 3618778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2020
• Initial Report FDA Received Date: 04/12/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention