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

Model Number	V200DNUS
Medical Device Problem Codes	Failure to Cycle (1142); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the led's to a smiths medical pneupac® parapac® ventilator were not cycling.There were no reported adverse effects.
Event or Problem Description
Investigation results completed on a smiths medical ventilators|pneupac ventilators ventipac.
Additional Manufacturer Narrative
Investigation results completed on a smiths medical ventilators|pneupac ventilators ventipac.Physical device was visually inspected and found to have front panel and gas supply indicator damage.Testing verified complaint and no leds alarms working.This was isolated to interface board and battery holder.Unknown what caused the problem.Other repair summary included : replaced damaged oring, and upgraded the check valve.Re-bent front panel.Installed pm kit 510a3039.Device passed all delivery testing.

• Brand Name: PNEUPAC® PARAPAC® VENTILATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9101417
• Report Number: 3012307300-2019-05071
• Device Sequence Number: 1825191
• Product Code: BTL
• UDI-Device Identifier: 35019315074183
• UDI-Public: 35019315074183
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: V200DNUS
• Device Catalogue Number: 130003V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 04/03/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2005
• 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: Unknown
• Patient Sequence Number: 1