MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 10 LEAD ECG TRUNK AAMI/IEC 2M; ECG TRUNK CABLE

Model Number M1663A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the ecg cable failed while in use with a defibrillator.The device was reported to be in use on a patient, causing a delay in therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Additional information has been requested.

Manufacturer Narrative

H10: the initial complaint was filed with incorrect registration number.See mfr report #96108816-2020-00183 for updated report.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.

• Brand Name: 10 LEAD ECG TRUNK AAMI/IEC 2M
• Type of Device: ECG TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9775720
• MDR Text Key: 181621355
• Report Number: 1218950-2020-01373
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00884838006652
• UDI-Public: (01)00884838006652
• Combination Product (y/n): N
• PMA/PMN Number: K020531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1663A
• Device Catalogue Number: M3536A
• Device Lot Number: 6C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1