MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX

Model Number M3535A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to philips healthcare that the device had an ecg equip malfunction inop message and ecg bias errors in the status log.There was no reported pt involvement or negative pt impact.

Manufacturer Narrative

(b)(4).

• Brand Name: HEARTSTART MRX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: phyllis mccarthy ; 3000 minuteman rd.; andover, MA 01810 ; 9786592811
• MDR Report Key: 4268076
• MDR Text Key: 5297785
• Report Number: 1218950-2014-06831
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2014
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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