MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX 3 WIRE (SNAP) AAMI; ECG LEAD SET

Model Number M3526A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

The customer reported a failure of a m3526a, ecg lead set 3 lead.There was no reported patient incident/injury.

Manufacturer Narrative

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

Event Description

The customer reported an intermittent failure of a (b)(4), ecg lead set 3 lead.The customer did not report any patient/user involvement.

• Brand Name: HEARTSTART MRX 3 WIRE (SNAP) AAMI
• Type of Device: ECG LEAD SET
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 4944831
• MDR Text Key: 17942662
• Report Number: 1218950-2015-03946
• Device Sequence Number: 1
• Product Code: DPS
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3526A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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