MAUDE Adverse Event Report: ST PAUL PARAPAC 200D TRANSPORT, MODEL V200D; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	130002V
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).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.No impact or corrosion damage present.The technician could not duplicate the reported issue.When applying backpressure at various levels, the audible reed alarm sounded at the corresponding pressure value on the relief alarm knob setting.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.The technician upgraded non-return valves (nrv)as a preventative.
Event or Problem Description
It was reported that the ventilator produced a high peep.No patient injury was reported.

• Brand Name: PARAPAC 200D TRANSPORT, MODEL V200D
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16633236
• Report Number: 3012307300-2023-03167
• Device Sequence Number: 12555242
• Product Code: BTL
• UDI-Device Identifier: 10610586045622
• UDI-Public: 10610586045622
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: 130002V
• Device Catalogue Number: 130002V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2010
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown