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

Model Number	100/905/340
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: expiration date and h4: manufacture date are not available based on the reported lot number.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
During pre-test, a crack near the base of the circuit was found.No patient involved.
Additional Manufacturer Narrative
Device evaluation: we received one device for investigation.Was unable to replicate the reported issue.We were unable to identify the root cause.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1.Please direct those to the following: regulatory.Responses@icumed.Com.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17304587
• Report Number: 3012307300-2023-07129
• Device Sequence Number: 6684493
• 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): 08/09/2024

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 Model Number: 100/905/340
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 2105045
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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