MAUDE Adverse Event Report: GE HEALTHCARE PEDIATRIC EKG TELEMETRY MONITOR; PEDIATRIC EKG ADAPTER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

The plastic sheath covering the metal prongs became dislodged when changing the patient ekg leads on the pediatric adapter being used for patient monitoring.On the next day, the patient was receiving a bath and changing ekg leads.The pediatric ekg adapter came apart during this time exposing metal prongs.The department representative indicated that their unit uses ge pediatric adapters to fit their unit's smaller patients.Clorox wipes are used to clean the adapters.This is not a recurring problem, although it happens every so often.

• Brand Name: PEDIATRIC EKG TELEMETRY MONITOR
• Type of Device: PEDIATRIC EKG ADAPTER
• Manufacturer (Section D): GE HEALTHCARE; 9900 w. innovation drive; mail stop rp-2138; wauwatosa WI 53226
• MDR Report Key: 5353093
• MDR Text Key: 35327068
• Report Number: 5353093
• Device Sequence Number: 1
• Product Code: DRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1