MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. STAGE 3 BOXING - PARAPAC PLUS 310 - POLAND; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE

Model Number 530A1167

Device Problem Defective Component (2292)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that the main knob blocked.No patient involvement reported.The outcome of the event was found during service.

Manufacturer Narrative

Udi is 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.

Manufacturer Narrative

Other, other text: one ventilator unit was received for investigation.The reported issue was confirmed during visual inspection when the unit was observed to have damage to its function switch housing and outer casing, which prevented the switch from operating.No previous service history.This damage was determined to be consistent with impact, and the root cause traced to user interface.Review of service records determined this device has not previously been serviced.As the reported issue did not occur during manufacturing, no review of the manufacturing device history record was necessary.The damaged housing components will be replaced.

• Brand Name: STAGE 3 BOXING - PARAPAC PLUS 310 - POLAND
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16069291
• MDR Text Key: 308254347
• Report Number: 3012307300-2022-28261
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: Health Professional
• Device Model Number: 530A1167
• Device Catalogue Number: 530A1167NPL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1