MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC PLUS 310 STAGE 3 BOXING, SWEDEN; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	530A1167NSE
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "bullet" that shows if there is incoming oxygen pressure does not always work.It stops halfway.There was no patient involvement.
Additional Manufacturer Narrative
The complaint was confirmed/replicated by device analysis.The cause was a damaged gas supply pressure indicator oxygen (o2).Changed gas supply pressure indicator o2 to correct the problem and functional testing performed.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 PLUS 310 STAGE 3 BOXING, SWEDEN
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20013983
• Report Number: 3012307300-2024-07898
• Device Sequence Number: 14534310
• Product Code: BTL
• UDI-Device Identifier: 35019315107478
• UDI-Public: (01)35019315107478(11)211117
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 530A1167NSE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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