MAUDE Adverse Event Report: BUTTERFLY NETWORK INC. BUTTERFLY IQ ULTRASOUND SYSTEM; POINT OF CARE ULTRASOUND

Model Number	N/A
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No user or patient injury was reported.The probe is being returned for investigation, but has not been received.Based on the information available to date, this event is being reported as a malfunction, though no malfunction has been confirmed.A follow up report will be submitted upon receipt of the returned device and outcome of the investigation.The medical device problem code, component code, type of investigation and investigation findings are pending the results of the failure investigation of the returned device.
Event or Problem Description
On (b)(6) 2020, a customer reported that the butterfly iq transducer (probe) got hot during the last use and that three days after the last use, the probe was found to have a crusty substance/material on the outside of the probe.Following the last usage, the customer reported that they stored the probe in a cloth pouch and discovered the substance/material three days later, when the probe was removed.Follow up information provided by the customer confirmed that the probe is typically stored in a cloth pouch with packets of ultrasound gel.Customer provided photos confirmed the substance/material.The probe is being returned for investigation.
Event or Problem Description
This is a follow up 1/final report to provide a conclusion to the investigation confirming no device malfunction.Reference initial report for event description.
Additional Manufacturer Narrative
Corrected data ref.A.1: (b)(6) is the correct identifier and has been updated in this follow up report.The identifier reported in the initial report was an error.Reference h.6: investigational findings - appropriate term/code not available investigation findings confirmed foreign contamination.Manufacturer narrative follow up 1/final: the initial report was filed after viewing customer photos and internal device logs.Once the probe was returned, the substance seen in customer-submitted photos was found on the exterior of the probe only.As no substance was found inside of the probe, butterfly determined the substance to be of external origin.Aside from intermittent connectivity issues due to the external substance coating some of the contacts on the lightning connector, the device passed all routine functional testing.No reportable device malfunction has been found.

• Brand Name: BUTTERFLY IQ ULTRASOUND SYSTEM
• Common Device Name: POINT OF CARE ULTRASOUND
• Manufacturer (Section D): BUTTERFLY NETWORK INC.; 530 old whitfield st; guilford CT 06437
• MDR Report Key: 11092102
• Report Number: 3010102386-2020-00002
• Device Sequence Number: 3698111
• Product Code: IYO
• UDI-Device Identifier: 00866646000206
• UDI-Public: 00866646000206
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K163510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1