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

Model Number	120002
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical pneupac ventilators parapac has rattling inside; loose body inside.No patient adverse effects reported.
Additional Manufacturer Narrative
H3: one pneupac ventilator parapac plus was returned with no physical damage found on the external of the device.The ventilator was opened and a visual inspection was conducted.The reported "loose body inside, rattling inside" issue was able to be duplicated.The issue was caused by a loose o-ring washer from the oxygen input fitting and loose packing wedges.The issue was user induced as the o-ring washer may have fallen if the oxygen input fitting was taken off.A new o-ring washer was installed and the packing wedges were refitted to resolve the issue.

• Brand Name: SMITHS MEDICAL PNEUPAC VENTILATORS PARAPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9163752
• Report Number: 3012307300-2019-05519
• Device Sequence Number: 1801315
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 120002
• Device Catalogue Number: 120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 03/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2011
• 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