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

Model Number	130003
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical pneupac ventipac ventilator alarms.No adverse effects were reported.No further information is available.
Additional Manufacturer Narrative
Corrected information: (item number updated from 130003v to 130003).
Additional Manufacturer Narrative
One ventilator was returned for evaluation.Visual inspection found the device to be in good physical condition.Device underwent functional testing for relief alarm pressure.The reported customer complaint was confirmed, resulting from a defective alarm reed.The problem source was determined to be normal wear and tear of the alarm reed; this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PNEUPAC VENTILATOR VENTIPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8976080
• Report Number: 3012307300-2019-04717
• Device Sequence Number: 18879067
• Product Code: BTL
• UDI-Device Identifier: 35019315074183
• UDI-Public: 35019315074183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/08/2020

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: 130003
• Device Catalogue Number: 130003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 12/11/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/09/2019; 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1