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

Model Number	P300NUS
Medical Device Problem Codes	Device Alarm System (1012); Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device will not end the breath.Keeps pumping and pushing air.Low battery alarm.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
No information has been provided to date.A product sample was received and is awaiting evaluation and 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
Other, other text: the date of event was 15aug2022.(updated b5 and b3).A product sample was received and is awaiting evaluation and 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
Additional information was received via email on 12-sep-2022.The event date was updated.Unknown if patient was involved.
Additional Manufacturer Narrative
Other text: h3.Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received with slight impact marks on the housing at the bottom right and top left.Continuous cycling was present.Unable to duplicate low battery alarm.The complaint was confirmed.A root cause could not be determined as the continuous flow was intermittent.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.The regulator and timing valve assembly were replaced.Device passed all functional and delivery tests., corrected data: h6 health effects - clinical signs and symptoms or conditions.

• Brand Name: PNEUPAC VENTILATORS PARAPAC PLUS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15401974
• Report Number: 3012307300-2022-18675
• Device Sequence Number: 6179029
• Product Code: BTL
• UDI-Device Identifier: 35019315107270
• UDI-Public: 35019315107270
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2023

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
• Device Model Number: P300NUS
• Device Catalogue Number: P300NUS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 09/29/2023
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/07/2022; 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown