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

Model Number	130003
Medical Device Problem Code	Device Alarm System (1012)
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.Device was received in with no apparent physical damages.The technician performed functional checks for the high pressure alarm via user manual.The reported problem was duplicated.The pneumatic alarm did not function at 20 centimeters of water (cmh2o) relief alarm pressure on settings flow 0.1, ti 1.5, te 3.0 for functional check.The root cause of the reported problem was found to be faulty alarm reed.The technician replaced alarm reed.
Event or Problem Description
It was reported that the high pressure alarm was not working.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: 16633240
• Report Number: 3012307300-2023-03168
• Device Sequence Number: 7170492
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 130003
• Device Catalogue Number: 130003
• 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: 10/05/2015
• 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