MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC BABYPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number B100NUS

Device Problems Device Damaged Prior to Use (2284); Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.They were received in wet and damaged packaging.The equipment in the damaged packages were also wet.Visual and functional testing were performed.Upon visual inspection, it was observed that six pieces of the device breathing circuits were missing.The tamper seal was still intact.There was damage to the patient valve of the device as well.The device was tested against the service test specifications associated with said device.The root cause of the reported issue was found to be caused by water damage and impact that occurred during shipping.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

Event Description

It was reported that two devices were received in wet and damaged packaging.It was reported that the equipment inside was also wet and missing six pieces of the breathing circuits.No patient injury was reported.

• Brand Name: PNEUPAC BABYPAC VENTILATOR
• 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): 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: 15401803
• MDR Text Key: 305878992
• Report Number: 3012307300-2022-18654
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K043495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: Health Professional
• Device Catalogue Number: B100NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1