MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC DISPOSABLE CIRCUITS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	100/905/340-CH
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product the customer maxed out the peep (positive end expiratory pressure) setting, but the actual value reached 12-14 cmh2o.No patient injury reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Visual inspection and functional testing was performed.Visual inspection found no abnormality in the appearance of the product.Functional testing found the positive end-expiratory pressure (peep) value was slightly lower than that of the normal product when the complaint product was connected to the parapack ventilator and operated.The root cause of the reported issue could not be determined.The product sample was returned to the supplier.This issue will be monitored in an internal scar for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.

• Brand Name: PNEUPAC DISPOSABLE CIRCUITS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15754434
• Report Number: 3012307300-2022-26895
• Device Sequence Number: 15032021
• Product Code: BTL
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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 Expiration Date: 02/15/2026
• Device Model Number: 100/905/340-CH
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 210315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown