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

Model Number M1674A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Contact office correction: (b)(4).

Event Description

The customer reported a failure of the ecg cable.There was no reported patient incident/injury.

Event Description

The customer reported a failure of the ecg cable wherein the ecg signal/waveform was intermittently being lost.The customer did not report any patient/user involvement.

• Brand Name: CBL 3 LEADSET, SNAP, IEC, ICU
• Type of Device: LEAD SET
• 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: 5078812
• MDR Text Key: 26192086
• Report Number: 9610816-2015-00204
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/26/2015

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: M1674A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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