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

Model Number M1668A

Device Problem Peeled/Delaminated (1454)

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

It was reported that the stickers on the ecg cables are peeling up.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text: the device is not available to be returned to philips for analysis.

• 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
• MDR Report Key: 9847539
• MDR Text Key: 187547149
• Report Number: 9610816-2020-00093
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• PMA/PMN Number: K020531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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: M1668A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR