MAUDE Adverse Event Report: GE HEALTHCARE GE HEALTHCARE RECHARGEABLE BATTERY; FLEX-3S3P

Model Number FLEX-3S3P

Device Problems No Display/Image (1183); Battery Problem (2885)

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

Event Type  malfunction  

Event Description

Battery failure during use in a surgery case on three different cases.Comes up with failure on display, but battery indicates 100% charged.These are on monitors that are less than 8 months old.

• Brand Name: GE HEALTHCARE RECHARGEABLE BATTERY
• Type of Device: FLEX-3S3P
• Manufacturer (Section D): GE HEALTHCARE; helsinki
• MDR Report Key: 4546581
• MDR Text Key: 20124573
• Report Number: MW5040910
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2015

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 Operator: Health Professional
• Device Model Number: FLEX-3S3P
• Device Catalogue Number: 2036984-001
• Device Lot Number: U80206
• Other Device ID Number: FLEX-3S3P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1