MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA AMBITION X

Model Number INGENIA AMBITION X

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hearing Impairment (1881)

Event Date 10/14/2020

Event Type  Injury  

Event Description

Philips received a report that a patient allegedly suffered hyperacusis and tinnitus in both ears after undergoing a spine examination on an ingenia ambition x mr system.

• Brand Name: INGENIA AMBITION X
• Type of Device: INGENIA AMBITION X
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 11257797
• MDR Text Key: 229578918
• Report Number: 3003768277-2021-00012
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838090040
• UDI-Public: 884838090040
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K18479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INGENIA AMBITION X
• Device Catalogue Number: 781356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/07/2021
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR