MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC VENTILATOR W/ ALARMS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	120003
Medical Device Problem Codes	Failure to Cycle (1142); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 did not deliver oxygen.There was no physical damage.There was no patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 10-apr-2024.Investigation summary: the affected device was returned for evaluation.Visual inspection performed.No missing or damaged components found.Functional testing performed.Could not duplicate customer issue.Device is delivering at an oxygen concentration of appprox.48.4 % on air mix and approx.100.3 % on nam.Device is operating within factory specifications.No action taken - due to obsolescence and lack of spare parts we are unable to complete the servicing of the ventilator.Device will be sent back un-repaired or scrapped on site.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 PARAPAC VENTILATOR W/ ALARMS
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19116066
• Report Number: 3012307300-2024-02632
• Device Sequence Number: 12538344
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: (01)10610586045486(11)190215
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• 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: Biomedical Engineer
• 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: Health Professional
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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