MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS 300 VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	P300NJJP
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that in august 2020, the ventilator had continuous cycling that occurred during inspection every morning.Resolved by repeating on/off.In september 2020, it occurred immediately after patient use.Switch to bvm.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: date returned to mfg.: 4/18/2024.H3 and h6.Evaluation codes: updated.One device was received.No abnormality related to the reported event was confirmed on the product's appearance.Functional testing was unable to confirm/duplicate the complaint.It is presumed that due to o-ring material/hardness of input manifold, inspiration and exhalation did not switch, and oxygen gas continued to come out of the outlet of main unit.The input manifold assembly was replaced as a preventive measure.The device passed all functional tests after repair.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PNEUPAC PARAPAC PLUS 300 VENTILATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19220801
• Report Number: 3012307300-2024-03215
• Device Sequence Number: 17868465
• Product Code: BTL
• UDI-Device Identifier: 35019315107270
• UDI-Public: (01)35019315107270(11)181221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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 Catalogue Number: P300NJJP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2018
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1275-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown