MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Event Description

Patient (toddler) was seen with a sticker.The rn looked closer and realized it was the sticker from the ecg cable.Patient peeled sticker off ecg cable.No patient harm but near miss because patient could have attempted to swallow it.Additional safety concern is now clinical staff do not know which ports the ecg electrodes should be plugged into on the cable due to the stickers falling off.The philips vendor reports that no other client of theirs has had this issue, yet each cable comes with 4 replacement stickers.

• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10046614
• MDR Text Key: 190644059
• Report Number: 10046614
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2020

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1095 DA