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 Problems Misconnection (1399); Output Problem (3005)

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

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a product sample was received for evaluation.The device was tested and passed all tests comparable with the manufacturing device history review.There was no instability and the readings remained stable.The device relief settings were rechecked numerous times with no change.The relief settings were all in specification with the user's settings.No fault found the device is functioning as expected.Manufacturing dhr reviewed and results are comparable.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the pressure set on the relief pressure control is exceeded.This was discovered during pre-test, not in use with patient.No patient injury reported.

• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; 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: 15402407
• MDR Text Key: 303344453
• Report Number: 3012307300-2022-18703
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 35019315107478
• UDI-Public: 35019315107478
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1