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

Catalog Number	120003
Medical Device Problem Codes	Device Alarm System (1012); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device was giving a constant low pressure alarm.There was no issue related to physical damage/abuse.The unit was not dropped at all.There was no delay of therapy.There was no patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for evaluation.The complaint was verified during testing.The main printed circuit board (pcb) assembly was contributing to the issue.Device was not functionally tested.No action taken due to obsolescence and lack of spare parts we are unable to complete the servicing of the ventilator.The device will be returned to the customer unrepaired or scrapped.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.

• Brand Name: PNEUPAC PARAPAC, MEDIC MODEL WITH ALARMS
• 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: 19183404
• Report Number: 9611178-2024-00079
• Device Sequence Number: 20685932
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: (01)10610586045486(11)160929
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 120003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2016
• 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