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

Catalog Number	120002
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing, the unit was not working properly.No patient involvement.No harm.
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.H3 - other: device has not been received 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.
Additional Manufacturer Narrative
D9 - date returned to manufacturing date-3/13/2024.One device was returned for evaluation.The device passed functional testing.Visual testing was not performed.The customer's reported problem was verified as it was due for preventative maintenance.The root cause was unknown.Preventative maintenance was performed, calibrated and cleaned on the device.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 MEDIC MODEL
• 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: 18888533
• Report Number: 3012307300-2024-01291
• Device Sequence Number: 16880600
• Product Code: BTL
• UDI-Device Identifier: 10610586045479
• UDI-Public: (01)10610586045479(11)070215
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 120002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2007
• 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