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

Model Number P310NUS

Device Problems False Alarm (1013); Display or Visual Feedback Problem (1184)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a false high pressure alarms constantly and the needle does not move when turned on.No patient injury was reported.Additional information was requested; however, no further information was received.

Manufacturer Narrative

Manufacturing device history record has been reviewed and deemed unrelated to the current customer reported reason.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a bent front panel at the top right, missing all small knob caps, housing damaged at the top right corner, and the input manifold is loose on the bottom chassis.Functional testing found high pressure alarmed on positive end-expiratory pressure (peep) at max only and the needle functions as intended on the manometer - positive end-expiratory pressure (peep) control needs to be re-set and the luer on the patient circuit needs to be connected to the manometer port.The root cause of the reported issue was found to be user error and impact damage.

Manufacturer Narrative

Other text: additional event information received indicating no patient involvement (updated b5).

Event Description

Additional info received via email 23-aug-2022.Event occurred during preventive maintenance.No patient affected.Event date updated.

• Brand Name: PNEUPAC PARAPAC PLUS
• 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): NULL; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; stores and receiving; minneapolis, MN 55442
• MDR Report Key: 15250526
• MDR Text Key: 298146175
• Report Number: 3012307300-2022-15601
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1