MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT WORN DEVICE; TELEMETRY

Model Number M4841A

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The response center clinical engineer, verified the issue with the customer over the phone.No onsite support was requested and none was provided.Post incident testing of the device confirmed this functionality of the device.The customer did not allege that this contributed to the event.The response center clinical engineer advised the customer on the functionality of disabling spo2 and how the parameter turns off.The telemetry technician did confirm that they received an inop message and acknowledged this message.The customer stated that they have started taping the sensors into the device.They also sent the customer the portion of the user guide that gives the warning about acknowledging this message and what happens once it has been acknowledged.

Event Description

The customer reported that after silencing the spo2 alarm on their telemetry transceiver, the spo2 parameter turns off.This is being reported as a serious injury.The customer did not allege that this issue contributed to the event.The available information is not sufficient to rule out that use of this device was causal or contributory to the patient outcome.

• Brand Name: PATIENT WORN DEVICE
• Type of Device: TELEMETRY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6325942
• MDR Text Key: 67259962
• Report Number: 1218950-2017-00920
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1