MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problem Bradycardia (1751)

Event Date 02/14/2024

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2024 at 3:17am the patient in bed imcu 247 had a brady cardiac event and the patient passed away.The customer requested assistance retrieving and reviewing the clinical audit logs after discharge in the piic ix as they are investigating the patient's death.It was also indicated the customer required assistance determining which alarms were silenced.A philips application specialist assisted the customer with the retrieval of alarm, stored waves and trends for the appropriate timeframe.The customer clinical manager stated the clinical audit shows on (b)(6) 2024 at 3:15am brady alarm event generated and the alarm was silenced.A philips technical consultant (tc) was dispatched for onsite service.The tc retrieved the logs and completed safety testing on devices used by this patient.The devices were found to be operating as expected.While there is no allegation in the record that the philips device caused or contributed to the patient death, this record will remain reportable out of an abundance of caution until further information is obtained to clarify the customer allegation.

Manufacturer Narrative

A philips field service engineer (fse) went onsite and pulled the requested logs.The fse also completed safety testing on the devices on which the patient was being monitored, as requested.The monitors were found to be functioning as intended.The complaint was escalated for technical investigation, and a product support engineer (pse) reviewed the data and advised that the audit log show multiple alarms: at 2:43, a "low hr" alarm generated, which was silenced at the patient information center ix (pic ix).The alarm limits were changed at 2:44 to lower the low alarm to 40.At 3:15, an "extreme brady" alarm was generated, which was silenced at telecl1.At 3:15:31, an "asystole" alarm generated, which was silenced at the imcusurv1 (pic ix) at 3:16.There continued to be alarms for "desat", "rr high", "hr high", "spo2 low", and "nbp low" until 3:55, when the patient was transferred to 1010.No product malfunction of the devices was found, as the audit logs indicates that most of the alarms were acknowledged promptly at the pic ix imcusurv1 or the telecl1.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The device remains in use.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18890899
• MDR Text Key: 337509417
• Report Number: 1218950-2024-00183
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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
• Patient Sex: Male