MAUDE Adverse Event Report: PEACE MEDICAL, INC. DEMISTIFIER; APPARATUS, GAS-SCAVENGING

Model Number 2000C

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2020

Event Type  malfunction  

Event Description

The demistifier 2000 is not up to the task of moving covid-19 patients over long distances.It is top heavy and has a tendency to tip.The canopy is easily caught in the wheels and tears off, the battery lasted at best 15 minutes and died 3/4 of the way from the ed to 360 thus was not able to provide negative flow.

• Brand Name: DEMISTIFIER
• Type of Device: APPARATUS, GAS-SCAVENGING
• Manufacturer (Section D): PEACE MEDICAL, INC.; 105 west dewey ave, bldg c-12; wharton, NJ 07885
• MDR Report Key: 10042701
• MDR Text Key: 190499325
• Report Number: 10042701
• Device Sequence Number: 1
• Product Code: CBN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2000C
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 730 DA