MAUDE Adverse Event Report: BG INDUSTRIES LLC ACCUMAX; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Failure to Pump (1502); Structural Problem (2506); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 10/17/2013

Event Type  malfunction  

Event Description

During a random audit it was discovered that 3 accumax air pumps were not working properly.The lights illuminated as if the equipment was working but there was no pumping air to the pad.The hospital bio-med department checked the 3 air pumps and all other accumax air pumps in our inventory.It was discovered that at some point the vendor began adding a wire tie to help support the transformer on each pump but it is unknown when that began and not all of our pumps had that.Our biomed department removed 3 pumps from service due to repairs not being economical.All were bg north america - model cu2.

• Brand Name: ACCUMAX
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): BG INDUSTRIES LLC; 8550 balboa blvd.suite 214; northridge CA 91325
• MDR Report Key: 3608189
• MDR Text Key: 4066791
• Report Number: 3608189
• Device Sequence Number: 3
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1