MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE TELEMETRY TRANSCEIVER

Model Number 862231

Device Problems Loss of Power (1475); Battery Problem (2885)

Patient Problem Death (1802)

Event Date 03/23/2019

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the staff did not observe the low battery alarm inop (inoperative) message and subsequently the telemetry device powered off.As a result, the patient was not being monitored and expired.It is unclear whether the device was being used on or off the network.

Manufacturer Narrative

The failed device was not returned to philips as of 14jun2019 for further evaluation.Philips was informed that the device was tested by a field service engineer and put back into service at the customer site.In the event that the device is returned, the record shall be reopened for further evaluation.The alarm logs were requested and it was found that the logs were overwritten because the logs were not retrieved for several days after the event.The customer has also stated that they do not believe the philips product was a factor in any way in the death of the patient.The root cause is unknown due to insufficient information and will be considered a malfunction.

• Brand Name: INTELLIVUE TELEMETRY TRANSCEIVER
• Type of Device: INTELLIVUE TELEMETRY TRANSCEIVER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8544798
• MDR Text Key: 142917783
• Report Number: 1218950-2019-03068
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000506
• UDI-Public: (01)00884838000506
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2009
• 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
• Patient Outcome(s): Death