MAUDE Adverse Event Report: SHARP CORPORATION OSAKA JAPAN FLOGARD; PUMP, INFUSION

Catalog Number 2M8063F

Device Problem Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint no: (b)(4).The device was serviced by a service technician as part of preventative maintenance.Visual inspection, functional testing, battery testing, and a review of the alarm log were performed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the event.A low battery alarm was identified during battery testing.The cause of the condition was determined to be a low battery.To correct the condition, the battery was replaced.The device was serviced to meet functional specification.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During product service by a service technician, a flo-gard infusion pump was found to have a low battery.No additional information is available.

• Brand Name: FLOGARD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SHARP CORPORATION OSAKA JAPAN; osaka ; JA
• Manufacturer (Section G): SHARP CORPORATION OSAKA JAPAN; osaka ; JA
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5221503
• MDR Text Key: 31073928
• Report Number: 1416980-2015-41769
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2M8063F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/1992
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1