MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BABYPAC FRENCH MODULE ASSAY; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	510A1960NF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event and d4: udi number 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
It was reported that there was a malfunction during the transfer of a newborns.Adverse patient effects are unknown and the outcome of the event was listed as resolved.
Additional Manufacturer Narrative
Other, other text: h6: evaluation codes updated.Device evaluation: one device was received.A visual inspection found the device in good condition except for the damaged patient valve.During the functional testing it was found that the alarm was not working reliably and there was a damaged patient valve that caused peep limits out of tolerance.Also the alarm reed is not squeaking.The electronics will be checked or replaced, the damaged patient valve will be replaced, and the alarm reed will be checked or replaced.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.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: BABYPAC FRENCH MODULE ASSAY
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 17857123
• Report Number: 3012307300-2023-09497
• Device Sequence Number: 3390249
• Product Code: BTL
• UDI-Device Identifier: 15019517181173
• UDI-Public: (01)15019517181173(11)180611
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 510A1960NF
• Device Catalogue Number: 510A1960NF
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 11/08/2023; Not provided
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 06/26/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• 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