MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PIC IX HARDWARE

Model Number 866424

Device Problems Alarm Not Visible (1022); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A follow up report will be submitted upon completion of the investigation.

Event Description

The customer reported that he wanted to know if the alarms on bed 14 were switched off and if so by what.The device was in use on a patient.There was no report of patient or user harm.

Event Description

The customer reported that he wanted to know if the alarms on bed 14 were switched off and if so by what.The device was in use on a patient.There was no report of patient or user harm.The logs were checked by the remote support engineer (rse) and he found that the unit was alarming from 01:02 on the 29/09 which was acknowledged at the central station.Then 01:07 which was acknowledged at the central station.Then from 01:09 to 01:35 the unit was alarming which was acknowledged at the bedside.And then the spo2 alarms were switched off at 01:46 but were switched back on.The philips engineer informed the customer that the spo2 alarms were switched off by the user.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15672040
• MDR Text Key: 302526674
• Report Number: 1218950-2022-00936
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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