MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PARAPAC PLUS 300 JAPANESE PANEL 1/UT; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P300NJ
Medical Device Problem Codes	No Device Output (1435); No Flow (2991)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; no information has been provided to date.One device was received.No physical damage was found on the device.Per functional testing, the reported event was not reproduced.The complaint was not confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action was taken since the complaint was not confirmed.
Event or Problem Description
It was reported that during patient use there was no ventilation.Adverse patient effects are unknown.
Additional Manufacturer Narrative
The following fields were updated with corrections: b5, h6 clinical & impact codes.
Event or Problem Description
It was reported that during patient use there was no ventilation.There was patient involvement and unknown patient harm/adverse event reported.

• Brand Name: PARAPAC PLUS 300 JAPANESE PANEL 1/UT
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; enterprise way; luton LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18402540
• Report Number: 9611178-2023-00014
• Device Sequence Number: 4020668
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)171116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2024

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 Model Number: P300NJ
• Device Catalogue Number: P300NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 07/30/2024; 07/30/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 08/07/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2017
• 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