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

Catalog Number	510A1960
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was showing results our of range during testing.It was also stated that the device exhibited continuous flow and did not ventilate.There was no patient involvement and no patient injury/harm.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection found the device in good condition.Functional testing was able to duplicate the reported problem.It was determined that the root cause was due to the faulty imv module.The imv module was replaced.The device then passed all functional testing.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: BABYPAC MODULE ASS.
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19660496
• Report Number: 3012307300-2024-05578
• Device Sequence Number: 20468132
• Product Code: BTL
• UDI-Device Identifier: 15019517181173
• UDI-Public: (01)15019517181173(11)150430
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K043495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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 Catalogue Number: 510A1960
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 12/01/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2015
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown