MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC MEDIC RESPONDER VENT; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	122002
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 reportable information becomes available.
Event or Problem Description
It was reported that during transport of a cardiac patient, they connected the respiratory circuit to the endotracheal tube (ett) and noticed the patient was not receiving adequate breaths.Upon inspection, they found that the rubber band around the positive end-expiratory pressure (peep) adapter was loose and out of place.They tested four different circuits before identifying one that functioned properly and allowed the patient to breath effectively.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
One device was returned for evaluation of complaint that the device there were no damages or anomalies observed.The sample was sent to the tpm for evaluation.The tpm investigation report states no nonconformances associated with the peep adapter.The investigation yielded no identification of any defects within the components.The root cause of the complaint was unable to be determined.

• Brand Name: PNEUPAC MEDIC RESPONDER VENT
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22861459
• Report Number: 3012307300-2025-09867
• Device Sequence Number: 13096230
• Product Code: BTL
• UDI-Device Identifier: 10610586046056
• UDI-Public: (01)10610586046056(11)270930
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 122002
• Device Lot Number: 0024131-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown