MAUDE Adverse Event Report: PNEUPAC¿ PATIENT CIRCUIT KITS; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Catalog Number	100/905/340
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a patient with a smiths medical pneupac¿ patient circuit was unable to be ventilated.The air circuit was then changed out; solving the problem.The following day the expiratory valve was noted to be "strange," causing leakage of gas.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Device evaluation: visual inspection: single limb circuit arrived with the patient valve in pieces but in good condition.The hose has no damage, splits or holes.The gauge connecter showed no signs of damage.The customer reported condition was not confirmed.No fault found.

• Brand Name: PNEUPAC¿ PATIENT CIRCUIT KITS
• Common Device Name: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• MDR Report Key: 8000510
• Report Number: 3012307300-2018-01856
• Device Sequence Number: 10813728
• Product Code: BYE
• UDI-Device Identifier: 15019315076107
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: No Information
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 100/905/340
• Device Lot Number: 180328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 06/27/2019
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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: Unknown
• Patient Sequence Number: 1