MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS KIT WITH INTERNAL PEEP; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number P310NUS

Device Problems Device Damaged Prior to Use (2284); Device Sensing Problem (2917)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

(b)(4).It was reported that dropped/high pressure alarm was continuously peeping.No patient injury was reported.

Manufacturer Narrative

The device was returned to smiths medical.Device was received in with a damaged front panel, battery cover, bottom casing, instruction label, and input/output label.The knobs do not stop at the end stops, they are also an incorrect style.The patient outlet fitting is loose, and the input manifold is loose on the bottom chassis.Connected to an o2 source checking the high-pressure alarm and performing a visual inspection.The root was cause was determined to be physical impact, due to the customer dropping the device.Replaced the casing and its labels, front panel, and electrical chassis.Replaced damaged rotary flow valve, input manifold assembly, gas supply indicator, and input block assembly.Replaced the function switch for a failed cpap.Corrected the o-ring seating in the sbv.Reset patient pressure cycling led.Adjusted cpap control needle due to output measurements not in tolerance.Installed mri battery, sintered filter, and o-rings for the pm.Performed pm testing, recalibrated unit, cleaned and affixed service label.Then, the device passed functional tests.

• Brand Name: PNEUPAC PARAPAC PLUS KIT WITH INTERNAL PEEP
• 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: 13481575
• MDR Text Key: 287812567
• Report Number: 3012307300-2022-02907
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: 35019315107263
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P310NUS
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1