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

Model Number	100/905/340-CH
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical ventilators|pneupac disposable circuits malfunctioned.During a pre-check, when the customer was checking for occlusion alarm from the product (a parapac plus), he noticed the indicator of the airway pressure meter did not go up.So he asked (b)(6) to check and repair the product.Then, (b)(6) checked the product using the dedicated pneumatic circuit and found that the airway pressure did not rise.Next, (b)(6) did it with (b)(6)'s own testing circuit and the product worked without problem.The customer requested us to check if there is any anomaly in the product.No patient injury.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms#(b)(4).The device was received for evaluation.During functional testing, using a dedicated pneumatic circuit and it was found that the airway pressure did not rise.However, using the manufacturer's own testing circuit, the product worked without problem.The device was checked to see if there was any anomaly in the product.It was confirmed that the pressure line tube connected to the ventilator had a dent and kinked when connected.Where the tube was kinked it was stuck inside and it was completely blocked, but it did release somewhat.During appearance check, the defect was confirmed.Root cause is unknown.However, no further action will be taken; a supplier corrective action is not required as this is not a defective case, and the reported problem is not associated with a trend.D2: product code is unknown.

• Brand Name: PNEUPAC DISPOSABLE CIRCUITS
• Common Device Name: 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): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 12381363
• Report Number: 3012307300-2021-08944
• Device Sequence Number: 11724544
• Product Code: BTL
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: 100/905/340-CH
• Device Catalogue Number: 100/905/340-CH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown