MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. STAGE 3 BOXING, PARAPAC PLUS, 310 POLAND; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 530A1167

Device Problems Fracture (1260); Incorrect, Inadequate or Imprecise Result or Readings (1535); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: udi number is unknown; no information has been provided to date.One device was received in good physical condition.Per functional testing the relief valve over limit-and need to be replaced, cycle led-over limit-need to be adjusted.The complaint was confirmed.The root cause was relief valve failure.It was unknown what caused the failure.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.Relief valve replaced and cycle light emitting diode (led) sensor adjusted.The device passed all functional and delivery tests.

Event Description

It was reported that the device would not pass the limit pressure test.Broken pressure limiter.There was no patient involvement and no patient or clinical injury.Obtained that the outcome of event is on going.

• Brand Name: STAGE 3 BOXING, PARAPAC PLUS, 310 POLAND
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17999642
• MDR Text Key: 326483207
• Report Number: 3012307300-2023-09860
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 530A1167
• Device Catalogue Number: 530A1167NPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1