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	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the ventilation volume was so insufficient.That the airway pressure meter did not work (or respond).No adverse effects reported.It was reported, that no further information is available.
Additional Manufacturer Narrative
B3: date of event.D4: lot number, expiration date.And h4: device manufacture date is unknown.No information has been provided to date.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
Upon review 21-july-2023 the aware date changed from 10-jan-2023 to 27-june-2023.This complaint was initiated as a result of testing to document a further component investigation.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection indicated that device had not been used on a patient.There was no abnormality in the appearance of the product.It was confirmed that the airway pressure gauge did not rise when setting the minimum tidal volume of the related ventilator.The complaint was confirmed.This has not been associated with a trend or pattern.This has been identified as a supplied item fault.The device history report (dhr) is stored at the supplier.Therefore no dhr review could be completed.The device will be sent to the supplier for further investigation.

• 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: 17283483
• Report Number: 3012307300-2023-07042
• Device Sequence Number: 15010841
• 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,Followup
• Report Date (Section B): 11/20/2023

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
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/10/2023
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 11/01/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/28/2023; 11/20/2023
• 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