MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BABYPAC MODULE ASSAY, SLOVAKIA; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	510A1960
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: date of event and d4: udi section are unknown, no information has been provided to date.G5: 510k is blank, this catalog number is not sold in the united states.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 device stopped cycling.Customer stated that no patient harm and medical intervention was recorded.
Additional Manufacturer Narrative
D4: udi updated **udi related data quality updates only.
Additional Manufacturer Narrative
Other, other text: device evaluation: one device was received for investigation.Visual inspection performed gauge bezel cracked, looks too used, and patient valve damaged.Functional test performed, device failed electronic and air leak test.Reported problem could not be duplicated.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.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: BABYPAC MODULE ASSAY, SLOVAKIA
• 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: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18007612
• Report Number: 3012307300-2023-09921
• Device Sequence Number: 6650977
• Product Code: BTL
• UDI-Device Identifier: 15019517181173
• UDI-Public: (01)15019517181173(11)230927
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2024

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: Other
• Device Model Number: 510A1960
• Device Catalogue Number: 510A1960NSK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 12/05/2023; Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 06/25/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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