MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC AFFINITI 70 - 795210; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 989605416151

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/05/2020

Event Type  Death  

Manufacturer Narrative

An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.

Event Description

A customer reported encountering an incident involving their affiniti ultrasound system becoming unresponsive during an emergency exam of a patient with a ruptured thoracic abdominal aortic aneurysm.The patient ultimately expired from the condition.The system failure occurred when alternating from a c5-1 to an s5-1 transducer.The system was promptly restarted to regain functionality.There was no allegation that the system lockup led to the patient¿s outcome.

Manufacturer Narrative

Design engineering performed a thorough evaluation on the returned system.They could not reproduce the reported problem of a system lockup or freeze when switching between c5-1 and s5-1 transducers.The system was put through different thermal testing scenarios and numerous boot cycles in which no errors or freezing was observed.The cause of the reported failure could not be determined.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: AFFINITI 70 - 795210
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9616898
• MDR Text Key: 175914673
• Report Number: 3019216-2020-00004
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: (01)00884838056251
• Combination Product (y/n): N
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605416151
• Device Lot Number: US918F0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR