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

Catalog Number 130003-00

Device Problem False Alarm (1013)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that there were high pressure alarms while the gauge read zero.No patient involvement was reported.

Event Description

Additional information was received indicating that the exact date of the event is unknown, but believed to have occurred somewhere around 22-february-2022.Confirmation that no patient was involved.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found minor wear and tear on the housing, no other apparent physical damages found.Functional testing found the high pressure led illuminates at all times due to faulty led printed circuit board (pcb).The root cause of the reported issue was found to be component failure.Replaced mri battery, o-rings and input filter for preventive maintenance.Replaced faulty led pcb to resolve the customer reported issue.

• Brand Name: PNEUPAC VENTIPAC
• 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: 14090514
• MDR Text Key: 289187929
• Report Number: 3012307300-2022-06257
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 130003-00
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1