MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC PARAPAC VENTILATOR W/ ALARMS P200D JAPAN; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P200DNUS
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation summary: the affected device was returned for evaluation.Started with a visual inspection.No abnormalities in the appearance of the product related to the reported event could be confirmed.Functional test / performance test conducted.It was confirmed that there was a gas leak from inside the main unit.The root cause is a leak from dislodgement due to aging of the tube.The disconnected tube was reconnected to correct the issue.P200dnamb device passed all the functional & performance tests after the repair.
Event or Problem Description
It was reported that there was a suspected leak.There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: PNEUPAC PARAPAC VENTILATOR W/ ALARMS P200D JAPAN
• 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19784222
• Report Number: 9611178-2024-00090
• Device Sequence Number: 8428572
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)120410
• 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
• Report Date (Section B): 07/19/2024

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 Model Number: P200DNUS
• Device Catalogue Number: P200DNJPAMBJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2012
• 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