MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 3 LEADSET, SNAP, IEC, ICU; ECG LEAD SET

Model Number M1971A

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 an ecg cable (lead set) problem.No patient incident/injury was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: CBL 3 LEADSET, SNAP, IEC, ICU
• Type of Device: ECG LEAD SET
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: nancy ataide ; 3000 minuteman road; andover, MA 01801 ; 9786597429
• MDR Report Key: 4284049
• MDR Text Key: 5297086
• Report Number: 9610816-2014-00249
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K020531
• 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
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M1971A
• Device Lot Number: 2012-08
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2014
• 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