MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M

Model Number M1668A

Device Problem Device Displays Incorrect Message (2591)

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.

Event Description

The customer reported that a healthy woman was being monitored while under anesthesia and the device reported an asystole alarm.Cpr was started before an assessment of the patient's vital signs was made.It was reported that blood pressure and respiration were being monitored at the same time as rcg.It was confirmed that there was no patient injury as a result of the treatment that was initiated.

Event Description

The customer reported a healthy woman was being monitored while under anesthesia and the device reported an asystole alarm.Cpr was started before an assessment of the patient's vital signs were made.It was reported that blood pressure and respirations were being monitored at the same time.Unnecessary emergent care was provided, that could have caused an injury to the patient.

• Brand Name: 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M
• Type of Device: ECG TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6135899
• MDR Text Key: 61452066
• Report Number: 9610816-2016-00308
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1668A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2016
• 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
• Patient Age: 26 YR