MAUDE Adverse Event Report: ALLIED MEDICAL LLC OPTIVAC; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number G180

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The batteries on 3 suction pumps failed prematurely and the pumps did not work.

• Brand Name: OPTIVAC
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ALLIED MEDICAL LLC; 1720 sublette ave; saint louis MO 63110
• MDR Report Key: 18939641
• MDR Text Key: 338112002
• Report Number: 18939641
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Device Model Number: G180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1