MAUDE Adverse Event Report: CHIARO TECHNOLOGY LTD. ELVIE BREAST PUMP DOUBLE MODEL EP01 (SGP); PUMP, BREAST, POWERED

Model Number EP01

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

Breast pump became very hot.Hot surface was not directly on skin due to a plastic insert, it would have caused a burn.It remained hot to the touch for quite a while.Model ep01 (sgp).Supplier agreed to replace it after internally reviewing temperature data.In the email stating they would replace it, they also mentioned another issue and said we should remove a bottle release button to be on the safe side.Is this a known safety issue? the email said: "some further information: we are aware of an issue affecting a small number of customers.You may not be affected by this, but to be on the safe side, please remove the bottle release button from your current hub and use this in your replacement" fda safety report id # (b)(4).

• Brand Name: ELVIE BREAST PUMP DOUBLE MODEL EP01 (SGP)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): CHIARO TECHNOLOGY LTD.
• MDR Report Key: 13592427
• MDR Text Key: 286234673
• Report Number: MW5107685
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EP01
• Device Catalogue Number: UNSURE
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female