MAUDE Adverse Event Report: ICU MEDICAL INTERNATIONAL LTD. PNEUPAC PARAPAC PLUS VENTILATOR KIT W/ INTERNAL PEEP & CPAP; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	P310NUS
Medical Device Problem Codes	Device Alarm System (1012); Failure to Cycle (1142)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit did not cycle breaths and had alarm issues.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 3012542015-2025-00005.The date of that submission was 27-jan-2025.B3.Date of event: unknown.No information has been provided to date.Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint could not be replicated and the root cause is unable to be determined.

• Brand Name: PNEUPAC PARAPAC PLUS VENTILATOR KIT W/ INTERNAL PEEP & CPAP
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ICU MEDICAL INTERNATIONAL LTD.; bijsterhuizen 22 ¿ 08; wijchen 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23696052
• Report Number: 3012307300-2025-13074
• Device Sequence Number: 21397029
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: (01)35019315107263(11)200523
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: Health Professional
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2020
• 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