MAUDE Adverse Event Report: SMITHS MEDICAL ASO, INC PNEUPAC PARAPAC PLUS VENTILATOR; ENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	P300NUS
Medical Device Problem Codes	Failure to Cycle (1142); Pressure Problem (3012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: other: device has not been returned to date.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 the device was not completing the full cycle and displayed a low-pressure error.No additional information is known.
Additional Manufacturer Narrative
D9: device received on 2/27/2025.H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional test were performed and could not confirm customers complaint of the device not completing full cycle.Cycling check worked as designed, however the alarms/leds were not working.The cause of the low-pressure error was found to be a defective electrical chassis assembly.The electrical chassis assembly was replaced to fix the issue as well as the issue of the alarms/leds not working.

• Brand Name: PNEUPAC PARAPAC PLUS VENTILATOR
• Common Device Name: ENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASO, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21358642
• Report Number: 3012307300-2025-01731
• Device Sequence Number: 15600856
• Product Code: BTL
• UDI-Device Identifier: 35019315107270
• UDI-Public: (01)35019315107270(11)220510
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: Other
• Device Catalogue Number: P300NUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown