MAUDE Adverse Event Report: ICU MEDICAL, INC. VENTILATOR MEDIC PARAPAC W/ALARMS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	120003
Medical Device Problem Codes	No Audible Alarm (1019); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned for analysis.No event history log provided.Product not returned.No evidence provided for review.No previous repair was noted for the last 12 months.Based on the review of information provided from the customer we are unable to determine a probable cause as the device was not returned for evaluation.Unable to confirm complaint as no device was returned.
Event or Problem Description
It was stated that device stopped working and it had no alarm - 45 seconds started working again then it stopped randomly.The event occurred while in use with patient.There was delay of therapy.There was patient involvement and unknown patient harm/adverse event reported.

• Brand Name: VENTILATOR MEDIC PARAPAC W/ALARMS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: reed covert ; enterprise way; bramingham business park; luton LU3 4-BU ; UK LU3 4BU ; 2247062300
• MDR Report Key: 22484955
• Report Number: 9611178-2025-00012
• Device Sequence Number: 15439445
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: (01)10610586045486(11)170328
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 120003
• 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: 05/30/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2017
• 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