MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P300NUS
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.Date of event is unknown, no information has been provided to date.
Event or Problem Description
It was reported that none of the ventilator alarms are working.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Additional information: b5 and h6, health effects codes: updated device evaluation: one device was received for investigation.Visual and functional testing confirmed the complaint, the device has no power and bent front.Customer and or physical damage was listed as the root cause of the failure.No previous service history was found.A manufacturing device history report (dhr) review was not relevant due to issue being user interface.The electrical chassis and mri battery were replaced.Sintered filter and o'rings for the preventative maintenance (pm).Reshaped bent front panel.Reset patient pressure cycling led to tolerance.Performed pm, recalibrated unit, cleaned and affixed new service label.The device passed all functional testing after the completed repairs.
Event or Problem Description
Additional information received that stated the issue was reported on 8-jan-2023 during testing of the unit.No patient harm/injury.

• Brand Name: PNEUPAC PARAPAC PLUS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2845 greenbrier road; minneapolis, MN 55442
• MDR Report Key: 16306032
• Report Number: 3012307300-2023-00915
• Device Sequence Number: 5927242
• Product Code: BTL
• UDI-Device Identifier: 35019315107270
• UDI-Public: 35019315107270
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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 Model Number: P300NUS
• Device Catalogue Number: P300NUS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown