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	Insufficient Device Problem Information (3190)
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 the product wasn't working.Event occurred before patient use, during testing.There was no patient involvement and no patient harmed reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection performed.No abnormality related to the reported event was confirmed on the product's appearance.Functional testing performed.When the device was operated, an event was confirmed in which exhalation was prolonged, confirming the customer's indicated failure.The root cause was due to a malfunction of the switch inside the demand detector.The product was returned to the customer without being repaired because the supply of the detector as a repair or replacement part had ended and it was no longer available.The 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: 19510678
• Report Number: 9611178-2024-00085
• Device Sequence Number: 14303965
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)121225
• 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): 07/15/2024

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: 05/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/16/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2012
• 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