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

Model Number	P200DN
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.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 even when the air mix was set to 45, it still flowed at 100.The fault occurred while in use with the patient.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: evaluation codes updated.One device was received for investigation.The device was visually inspected and functionally tested.The reported problem was confirmed.The root cause is that the flow block failed.The flow block assembly will need to be replaced; however, the product was returned to the customer without being repaired because the supply of the flow block as a repair or replacement part had ended and it was no longer available.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 INTERNATIONAL LTD.; enterprise way; bramingham business park; luton LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21047953
• Report Number: 9611178-2024-00098
• Device Sequence Number: 3409122
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)130508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: P200DN
• Device Catalogue Number: P200D/NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2013
• 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