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

Catalog Number	P310NUS
Medical Device Problem Codes	Intermittent Continuity (1121); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: one device was received for evaluation.Service history review was not performed.The customer¿s issue was confirmed as the device was tested and it had continuous flow when it was set to ventilate.
Event or Problem Description
It was reported that the unit was stuck in extrapory mode and would not function unless it was shut off, and that the issue was intermittent and the pump was not dropped.There was no patient involvement.

• Brand Name: PNEUPAC PARAPAC PLUS VENTILATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; bijsterhuizen 22 ¿ 08; wijchen 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24488864
• Report Number: 3012307300-2026-01891
• Device Sequence Number: 5105108
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: (01)35019315107263(11)240712
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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