MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ECG 5-LEAD GRABBER, AAMI-SPO2, TELE; TELEMETRY PACK LEADS

Catalog Number 989803171851

Device Problems Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

Gasket came loose in the part of the lead set that connects to the telemetry pack.This caused failure of the pt's ekg signal to transmit to the central station.Telemetry pack worked fine with a new lead set.

• Brand Name: ECG 5-LEAD GRABBER, AAMI-SPO2, TELE
• Type of Device: TELEMETRY PACK LEADS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; andover
• MDR Report Key: 5905957
• MDR Text Key: 53333370
• Report Number: MW5064354
• Device Sequence Number: 1
• Product Code: IKD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 989803171851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other