MAUDE Adverse Event Report: PEACE MEDICAL DEMISTIFIER 2000C; GAS SCAVENGING DEVICE

Model Number 2000C

Device Problems Premature Discharge of Battery (1057); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

During the investigation it was found that the device was installed on a stand not shipped with the unit in 2009.A counter balance weight was shipped and placed to address top heavy complaint.Stanford biomedical engineering found the battery life to be over 5.5 hours when battery was fully charged.The battery had been run down without being plugged in to recharge the battery.It was determined that staff training was needed.Training video was sent to biomedical engineering.Biomedical engineering indicated they were fully satisfied with the peace medical's response.That being said, the demistifier 2000c product was discontinued in 2011.

Event Description

The demistifier 2000c is not up to the task of moving covid-19 patients over long distances it is top heavy.The canopy is easily caught in the wheels and tears off.The battery lasted at best 15 minutes and died.

• Brand Name: DEMISTIFIER 2000C
• Type of Device: GAS SCAVENGING DEVICE
• Manufacturer (Section D): PEACE MEDICAL; 105 west dewey ave, bldg c-12; wharton, nj
• Manufacturer (Section G): PEACE MEDICAL INC; 105 west dewey ave, bldg c-12; wharton, nj
• Manufacturer Contact: tim fegan ; 105 west dewey ave, bldg c-12; wharton, nj ; 6722120
• MDR Report Key: 10433213
• MDR Text Key: 204515632
• Report Number: 0002243990-2020-00001
• Device Sequence Number: 1
• Product Code: CBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse Practitioner
• Remedial Action: Other
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: 2000C
• Initial Date Manufacturer Received: 05/10/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 YR