MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M; TRUNK CABLE

Model Number M1669A

Device Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

Serial number not provided.Phone not provided.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer stated that the plastic on the cable completely melted revealing the metal part there was no reported patient incident injury.

Event Description

The customer stated that the plastic on the cable completely melted revealing the metal part.There was no reported patient incident injury.

• Brand Name: CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M
• Type of Device: TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8662829
• MDR Text Key: 146916680
• Report Number: 1218950-2019-03940
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00884838011632
• UDI-Public: (01)00884838011632
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1669A
• Device Catalogue Number: 989803145071
• Device Lot Number: 2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• 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