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

Catalog Number	P200D/NJJP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: 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 there was damage to the switch cover.The fault occurred before in use with the patient.It was reported that there was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
After further review, this file is no longer considered a reportable event.The event does not meet the definition of a reportable death or serious injury as the malfunction of the device did not cause or contribute to a patient death, a life-threatening event, permanent impairment of a body function or structure, required medical or surgical intervention to preclude serious impairment of a body structure or function.Additionally, the reportable malfunctions list indicates that the device in the reported incident would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, mfr# 9611178-2024-00087 will be cancelled.

• 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: 19510676
• Report Number: 9611178-2024-00087
• Device Sequence Number: 16995349
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)090106
• 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): 07/23/2024

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 Catalogue Number: P200D/NJJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/23/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2009
• 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