inforMED
MalfunctionDSA

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Received May 12, 2020 · Event occurred Feb 17, 2020

Report 10046614 · MDR key 10046614

Device

Generic name

Cable, Transducer And Electrode, Patient, (including Connector)

Product problems

  • Detachment of Device or Device Component

Patient

1095 DA

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

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.