MAUDE Adverse Event Report: ICU MEDICAL, INC. PNEUPAC PARAPAC PLUS 310 STAGE 3 BOXING; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	530A1167
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
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 information becomes available.
Event or Problem Description
It was reported that there was internal gas leakage.There was no patient involvement.

• Brand Name: PNEUPAC PARAPAC PLUS 310 STAGE 3 BOXING
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; bramingham business park; luton LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24271287
• Report Number: 3012307300-2026-00966
• Device Sequence Number: 9948192
• Product Code: BTL
• UDI-Device Identifier: 35019315107478
• UDI-Public: (01)35019315107478(11)160919
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 530A1167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2016
• 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