MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC; VENTILATOR, EMERGENCY, POWERED

Catalog Number	120002
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device has a rattling noise and needs a pm.The issue was not related to physical damage/abuse or dropped.There was no patient involvement, and no harm/adverse event was reported.
Additional Manufacturer Narrative
After further review, this was found to be a non-reportable event.The event does not meet the definition of a reportable death or serious injury as the malfunction of the device did not cause or contribute to a patient death, a life-threatening event, permanent impairment of a body function or structure, required medical or surgical intervention to preclude serious impairment of a body structure or function.Additionally, the reportable malfunctions list indicates that the device in the reported incident would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, mfr# 3012307300-2024-03992 will be cancelled.

• Brand Name: PNEUPAC PARAPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19360402
• Report Number: 3012307300-2024-03992
• Device Sequence Number: 19765064
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: 10610586045479
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 120002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown