MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the defibrillator has a stained display which makes it difficult or even impossible to see information on the screen.The event occurred during clinical use, but there was reportedly no patient harm.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: brian becker ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 10320907
• MDR Text Key: 201509636
• Report Number: 1218950-2020-04309
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2007
• 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