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

Model Number 120003

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.Upon visual inspection, it was observed that the case, battery holder, and alarm bezel were all damaged.Customer reported problem of physical damage to the device was able to be confirmed.The root cause of the reported issue was found to be due to impact, most likely caused by interfacing with the user.Repair actions include replacing the case enclosure, the battery holder, and the alarm bezel along with recalibrating the device.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D5 operator of device is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that when the customer received the device, they observed physical damage to it right out of the box.No patient injury was reported.

• Brand Name: PNEUPAC PARAPAC VENTILATOR
• 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: 15397730
• MDR Text Key: 306003076
• Report Number: 3012307300-2022-18523
• 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: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1