MAUDE Adverse Event Report: BUTTERFLY NETWORK INC. BUTTERFLY IQ CHARGER; WIRELESS SYSTEM CHARGER

Model Number WTD1A05

Device Problems Thermal Decomposition of Device (1071); Electrical Shorting (2926); No Apparent Adverse Event (3189)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Follow up with the user confirmed that there was no injury or impact to any patients, users, or other persons.Butterfly iq ultrasound system design prevents the butterfly iq probe from being used to scan while charging; therefore, this event does not represent a hazard to patients.The event was identified when the user returned the butterfly iq probe to the charger after use but could not confirm if the probe was on the charger at the time of the event.The customer confirmed that the butterfly network supplied charging pad, cable and wall adapter were used in accordance with the user manual and that no non-butterfly or aftermarket adapters or connectors were used.No user or environmental factors were identified to cause or contribute to the charger malfunction.In addition to the butterfly iq charger, the user's butterfly iq probe was requested to be returned for analysis to ensure the probe was not affected by the event.The complaint-related butterfly iq charger and user's butterfly iq probe were received on 26 sep 2020 for investigation.The user's butterfly iq probe was evaluated and passed all standard investigational tests confirming that the device was operating as expected with no device malfunctions or damage.Visual inspection of the butterfly iq charger confirmed the reported condition.Initial failure analysis investigation of the butterfly iq charger components confirmed an electrical short circuit in the connection between the charging pad and charging cable.The investigation is ongoing to identify the root cause.A follow up report will be submitted with the results of the investigation.

Event Description

On (b)(6) 2020, a user reported that the butterfly iq charger malfunctioned stating "the ultrasound charging pad has a melted port.The cables and wall adapter were the original ones that came with the ultrasound." the customer provided photos of the defect and damage.The butterfly iq charger and the user's butterfly iq probe were returned for investigation.

Manufacturer Narrative

Follow up 2/final narrative: the failure investigation for butterfly iq charger pad (b)(4) has been finalized.No manufacturing defect or design defect was identified. the investigation of the butterfly iq charger pad, cable and wall adapter included visual inspection, preliminary investigation, x-rays, destructive testing of the failed charger and testing of similar chargers (same part number) to reproduce the confirmed failure.  the failure mode was an overheating of the connector which led to plastic melting and the connection being broken.After x-rays and destructive testing, the failure mechanism was determined to be isolated to the connection between usb plug and usb receptacle.Reproduction of the failure was achieved through testing with similar chargers (same part number) and concluded that a somewhat conductive liquid contamination (such as an acid, base, or electrolyte) in the connection between the usb plug and usb receptacle of the charger pad is the likely root cause for this failure.

Event Description

This is a follow up 2/final report to provide a conclusion to the investigation.Reference initial report for event description.

Manufacturer Narrative

Follow up narrative: the failure investigation has not yet been finalized.No manufacturing defect or design defect has been identified.As part of the failure investigation, butterfly engineers attempted to reproduce this event with several liquid contaminants.This event was able to be reproduced with one of the liquid contaminants.While the investigation is ongoing, no other likely root causes have been identified.The likely root cause of this failure is accidental liquid contamination in the connection between the charger pad port and the charger cable connector.A follow up/final report will be submitted upon completion of the investigation report.

Event Description

This is a follow up report to provide an update to the investigation.Reference initial report for event description.

• Brand Name: BUTTERFLY IQ CHARGER
• Type of Device: WIRELESS SYSTEM CHARGER
• Manufacturer (Section D): BUTTERFLY NETWORK INC.; 530 old whitfield st; guilford CT 06437
• MDR Report Key: 10674288
• MDR Text Key: 211219892
• Report Number: 3010102386-2020-00001
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00866646000268
• UDI-Public: 00866646000268
• Combination Product (y/n): N
• PMA/PMN Number: K163510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WTD1A05
• Device Catalogue Number: N/A
• Device Lot Number: 1100310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2020
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1