MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL

Device Problems Component Falling (1105); Device Markings/Labelling Problem (2911)

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

Event Date 02/15/2017

Event Type  malfunction  

Event Description

Approx 3 telemetry transmitter labels had fallen off the transmitter battery covers.The labels indicated the channel number the patient would be monitored on.The nursing staff tried to relabel the transmitters and match them to the channel number, but improperly labeled the wrong channel on the wrong transmitter.When a patient experienced an episode of bradycardia, her ekg was displaying normal at the central station.The nurse assessed and treated the patient according to her vital signs taken manually.Biomed was called by staff during the night.The transmitters were properly labeled, no more labels were applied to the battery cover and battery doors were replaced.Channel labels are placed on the transmitter box.This equipment is out of support by philips and is being replaced in may 2017.

Event Description

Three telemetry transmitter labels had fallen off the transmitter battery covers.The labels indicated the channel number the patient would be monitored on.The nursing staff tried to relabel the transmitters and match them to the channel number, but improperly labeled the wrong channel on the wrong transmitter.When a patient experienced an episode of bradycardia, her ekg was displaying normal at the central station.The nurse assessed and treated the patient according to her vital signs taken manually.Biomed was called by staff during the night.The transmitters were properly labeled, no more labels were applied to the battery cover and battery doors were replaced.Channel labels are placed on the transmitter box.This equipment is out of support by philips and is being replaced in may 2017.

• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6547163
• MDR Text Key: 74515296
• Report Number: 6547163
• Device Sequence Number: 1
• Product Code: DRG
• 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,Followup
• Report Date: 04/18/2017,04/26/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1