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

Catalog Number	P310NUS
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Found the unit¿s battery door was damaged and the relief alarm pressure knob is broken and both require replacement.During evaluation, the unit failed tidal volume.Troubleshot issue and found that the tidal volume knob will rotate past the end set points on the high and low ends.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: the suspected device was returned for evaluation.The customer reported issue of "the unit¿s battery door was damaged" was not confirmed because the battery cover is missing.Customer complaint of ¿the relief alarm pressure knob was broken¿ was confirmed.The customer complaint of ¿the unit failed the tidal volume test.Troubleshooting revealed that the tidal volume knob could rotate past the end set points on both the high and low ends during testing.¿ was confirmed.During visual inspection the battery door was found to be missing, and the relief alarm pressure knob was cracked.Further inspection revealed that the tidal volume knob was not correctly tightened on the shaft which resulted in the knob turning past the endpoint stops causing the volume setting to read incorrectly.The battery cover and relief alarm pressure knob were replaced.The tidal volume knob was secured to the shaft and calibrated.Device now passes visual inspection and all frequency and tidal volume tests.Probable cause of the damaged battery cover is unknown as it was missing from the device.Probable cause of the broken relief alarm pressure knob was normal wear/life.Probable cause of the tidal volume was a loose knob.Device repair was not completed at the time of this investigation due to part supply shortages.(rotary flow valve) will be repaired and returned to customer once the part arrives.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: PNEUPAC PARAPAC PLUS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23908605
• Report Number: 3012307300-2025-13845
• Device Sequence Number: 9038522
• Product Code: BTL
• UDI-Device Identifier: 10610586029554
• UDI-Public: (01)10610586029554(11)211130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: P310NUS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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