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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation.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 the customer applied a 20cmh2o of air pressure to the product during the pre-use check, but it fell down to 13cmh2o.He suspects there is a hole or leakage of air in the product.The reported lot number could not be verified.No patient injury reported.
Additional Manufacturer Narrative
Other text: h3.Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received.No visual defects were noted.A functional leak test was performed, and the device failed.The complaint was confirmed.The root cause was due to a supplied item.The device history record (dhr) is retained by the supplier and not readily available for review.This issue will be monitored, and further actions taken accordingly.

• 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: 16157554
• Report Number: 3012307300-2023-00455
• Device Sequence Number: 17886903
• 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): 09/11/2023

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 Model Number: 100/905/340-CH
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 210203
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/22/2022
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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