MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SINGLE LIMB CIRCUIT PNEUPAC PARAPAC EXPIRATORY PORT FLOW DIVERTER; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Catalog Number	100/905/340-CHJS
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the relief pressure did not increase when parapac plus was used on a pediatric patient at the low flow setting.After having the parapac plus investigated it was determined that the problem was most likely on the circuit side.The event occurred during patient use, no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.One device was received.Per visual inspection, no abnormality related to the reported event was confirmed on the product's appearance.Per functional testing, when the product is connected to the parapac plus and the test lung is connected to the patient valve of the product, when the ventilation volume setting of the parapac plus is operated at the minimum 70ml or a value close to it, the pressure inside the patient circuit/airway, the pressure on the pressure gauge does not rise.The complaint was complaint/duplicated.A root cause could not be identified, and the issue was reported to the supplier.The device history record (dhr) is at the supplier and not readily available for review.

• Brand Name: SINGLE LIMB CIRCUIT PNEUPAC PARAPAC EXPIRATORY PORT FLOW DIVERTER
• Common Device Name: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19911620
• Report Number: 3012307300-2024-07173
• Device Sequence Number: 21033379
• Product Code: BYE
• UDI-Device Identifier: 15019315076107
• UDI-Public: (01)15019315076107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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: 100/905/340-CHJS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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