MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON

Model Number M2736A

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the m2736a avalon us transducer was aimed at the patient and produced strong heat.The patient had heavy redness at the aimed spots (1st degree burn).The plastic of the m2736a avalon us tranducer changed as well.

Event Description

The customer reports that the us-recorder was aimed at the patient and it produced strong heat.The patient had heavy redness at the aimed spots; the plastic of the us-recorder changed as well due to the heat.Patient experienced first-degree burns; no adverse event was reported.

• Brand Name: ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• MDR Report Key: 5155510
• MDR Text Key: 28848595
• Report Number: 9610816-2015-00235
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2736A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2011
• 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