MAUDE Adverse Event Report: PHILLIPS MEDICAL SYSTEMS SERIES C; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU

Model Number M2601

Device Problems Device Slipped (1584); Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

While attempting to place patient on telemetry transmitter, hooked transmitter up to patient, went back to central station and there was no ekg signal.Staff replaced battery - still no signal.Reported to biomed; upon evaluation, noted ekg ribbon cable loose.Biomed plugged ribbon cable back into lead contact.Functional test completed - passed.Transmitter placed back in service.

• Brand Name: SERIES C
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU
• Manufacturer (Section D): PHILLIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 4137610
• MDR Text Key: 4950030
• Report Number: 4137610
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/25/2014

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: Nurse
• Device Model Number: M2601
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2014
• Patient Sequence Number: 1