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

Catalog Number	120003
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device was missing a knob and preventive maintenance was needed.They verified with their biomed technical: "outside of the missing knob with cap there is no other physical damage to suggest it was dropped".No patient involvement reported with this incident and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection done.The missing knob was found during visual inspection.The issue was confirmed.The cause is traced back to mishandling from the user.Replaced on/off control knob/cap.The device passed all functional test.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 PLUS, MEDIC MODEL WITH 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18975319
• Report Number: 3012307300-2024-01671
• Device Sequence Number: 20475665
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: (01)10610586045486(11)080305
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 120003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2008
• 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