MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS PARAPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 120003

Device Problems Device Damaged Prior to Use (2284); Component Missing (2306); Battery Problem (2885)

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

Event Type  malfunction  

Event Description

It was reported that, during testing, the device had no battery power, the housing was damaged and the knob covers were missing.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes to the customer's reported problem were found during the device history record (dhr) review.The device was received for evaluation, in damaged condition with missing knobs, broken face plate, and damaged corner by the battery holder door.Functional test was performed: turned device on to troubleshoot the battery and the device did not power on; the reported issue was confirmed.The device was opened for further investigation and multiple components were found to be corroded: battery door, holder, screws on the back side, and the inside of the device.Leds were not functioning properly during performance check as was alarming continuously low pressure.Multiple components failed due to damage and corrosion which indicates the device was mishandled.Problem source was deemed to be damaged components and normal wear and tear.Action(s) taken to mitigate the reported issue(s): replaced battery holder and interface board, led, main alarm; device then functioned as intended and passed all functional tests.

• Brand Name: PNEUPAC VENTILATORS PARAPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15606174
• MDR Text Key: 306338524
• Report Number: 3012307300-2022-24045
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1