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

Model Number 530A1167

Device Problems Inaccurate Flow Rate (1249); Tidal Volume Fluctuations (1634); Volume Accuracy Problem (1675); Key or Button Unresponsive/not Working (4063)

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

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event and d4: udi section are 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 Description

It was reported that the volume knob turned 360 degrees, not blocking at the minimum or maximum levels.This resulted in incorrect volume values.The device was last serviced or checked on (b)(6) 2023 and was not in patient use when the problem occurred.

• 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: 17597014
• MDR Text Key: 322315234
• Report Number: 3012307300-2023-08248
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 530A1167
• Device Catalogue Number: 530A1167NPL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1