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

Model Number	130003
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gauge housing was cracked and gauge was at an angle.No patient injury was reported.Additional information received 6-oct-21: event date was (b)(6) 2021, found in attempt to perform preventative maintenance.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual inspection was performed.Device was received in with damages on the case around the battery compartment as well as the battery holder, bent front panel, missing small knobs, cracked gas supply indicator and missing shroud, cracked bezel, and the manometer was not in its correct position.The technician confirmed the reported issue by visual inspection.The root cause of the reported issue was an impact to the device caused by the customer.The technician replaced the gauge bezel and light-emitting diode (led) and re-positioned the manometer.

• 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: 16633162
• Report Number: 3012307300-2023-03161
• Device Sequence Number: 7150106
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• 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: 10/06/2021
• 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: 03/08/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2005
• 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