MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. STAGE 3 BOXING, PARAPAC PLUS, 310 FRENCH; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	530A1167NFR
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.One device was received.The device was visually checked, and no issues were found.Functional tests were performed and found that the o-ring needs to be changed confirming the complaint.The will be o-ring changed and functional and delivery tests performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
Event or Problem Description
It was reported that the device has been sent for preventive maintenance.There was no patient involvement, no patient harm.
Additional Manufacturer Narrative
While performing a review of the event, it was determined that the reported issue did not meet the criteria for a complaint.No deficiencies were alleged regarding the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Please disregard mrn 3012307300-2024-05297 and any reports associated with it.

• Brand Name: STAGE 3 BOXING, PARAPAC PLUS, 310 FRENCH
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19586267
• Report Number: 3012307300-2024-05297
• Device Sequence Number: 20680607
• Product Code: BYE
• UDI-Device Identifier: 35019315107478
• UDI-Public: (01)35019315107478(11)220224
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123957
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 530A1167NFR
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown