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

Model Number P310NUS

Device Problem No Flow (2991)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported that the flow switch is not working and cpap flow will not turn on.No patient involvement was reported.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device was received in with a cracked peep knob and missing four small end caps, the cpap knob contains marks, bottom casing contains a minor crack, the threads on the vrv block manifold have stripped, variable relief valve is now loose.Internal inspection shows contamination of foreign material.The customer stated problem was duplicated, unable to spin the knob to its min and max settings.Replaced bottom chassis, vrv block manifold, housing, function switch, and 2 small knobs.Installed mri battery, sintered filter, and o-rings for the pm.Reset patient pressure cycling led and adjusted cpap control to tolerance.Performed pm, cleaned device and affixed new service label.The cause of the reported problem was traced to the customer manipulation of the device.The previous service history has been reviewed and is deemed unrelated to the current customer reported problem.

• 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; minneapolis, MN 55442
• MDR Report Key: 14089849
• MDR Text Key: 289174623
• Report Number: 3012307300-2022-06245
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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 Model Number: P310NUS
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1