MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VENTIPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	130003
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device 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 the patient circuit connector was too loose and wouldn't work correctly, causing internal leakage.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4.Primary udi number: (b)(4).Investigation summary: the affected device was returned for evaluation.Visual inspection performed.Device was in good condition, no signs of external damage.Connected to oxygen supply and performed lock off leak test.Customer's reported issue was confirmed.User interface/demand valve screw cap was found loose.Tightened and secured patient output connector and demand valve screw cap to correct the issue.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18610466
• Report Number: 2183161-2024-00119
• Device Sequence Number: 2406058
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: (01)10610586038259(11)070511(21)0703299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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 Catalogue Number: 130003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2007
• 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