MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VR1 STANDARD; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	520A1299
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event 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 green manual ventilation button was missing.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
D4: correction h3: one device was returned for analysis in used condition.Visual inspection showed the manual button is broken.Service history identified the complaint was not related to a previous service of the device within the review period.The cause of the damage was identified to be impact to the device.The device has been deemed beyond economical repair due to obsolete components needed to complete final testing and will be scrapped onsite or returned incomplete.

• Brand Name: PNEUPAC VENTILATORS VR1 STANDARD
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18988381
• Report Number: 3012307300-2024-01737
• Device Sequence Number: 2858347
• Product Code: BTL
• UDI-Device Identifier: 10610586045721
• UDI-Public: (01)10610586045721(11)091030(21)0910307
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 520A1299
• Device Catalogue Number: 520A1299US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2009
• 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