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

Model Number	120002
Medical Device Problem Codes	Defective Component (2292); Device Fell (4014)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical pneupac parapac ventilator was dropped causing limited adjustment of the tidal volume.There were no reported adverse effects.
Additional Manufacturer Narrative
Other, other text: additional information- device issue did not involve a patient.Added to section b5.Device evaluation- the device was returned for evaluation.The examination of the device showed housing was cracked.Testing was performed and this showed the manometer was not within specification and the tidal volume knob was stuck.Further examination showed a component (shim) had shifted and jammed the tidal volume switch.This component was likely dislodged and stuck in this position as a result of drop damage.
Event or Problem Description
Reported issue did not occur during use with patient.

• Brand Name: PNEUPAC PARAPAC VENTILATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 10557225
• Report Number: 3012307300-2020-09564
• Device Sequence Number: 2670000
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: Health Professional
• Device Model Number: 120002
• Device Catalogue Number: 120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2007
• 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