MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PNEUPAC PARAPAC VENTILATOR MEDIC MODEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	120003
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-checkout the mri vent has a loud leak when turned on, which sounded internal.All external connections were checked and were tight.A rush of air was felt from the front dial.There was no patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D4 - primary udi number: corrected.D9: date returned to mfg.: unknown.H3 and h6.Codes: updated.One device was received for evaluation.All external connections were checked and are tight.A rush of air was felt from the front dial.This was verified during inspection.The demand valve assembly was contributing to the issue.Due to obsolescence and lack of spare parts we are unable to complete the service of the ventilator.The device will be sent back un-repaired or scrapped on site pending customer response.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 VENTILATOR MEDIC MODEL
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19934475
• Report Number: 3012307300-2024-07325
• Device Sequence Number: 7433463
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: (01)10610586045486(11)101201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 120003
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2010
• 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