MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH UNKNOWN PATIENT MONITORING PIIC

Catalog Number UNK238-PIIC

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer is requesting log files after the incident.There was a reported patient death.

Manufacturer Narrative

This record is a duplicate of (b)(6).The case was further evaluated in consideration of all available information.Case notes indicate that there is no allegation of philips monitoring contributing to this issue.Audit review determined that the monitor had generated several technical, as well as two and three star alarms.Among others also xbrady and asystole.These alarms were acknowledged at 22:23 at the bed (monitor mt22000734).Therefore, this record has been deemed not-reportable.

• Brand Name: UNKNOWN PATIENT MONITORING PIIC
• Type of Device: UNKNOWN PATIENT MONITORING PIIC
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15520864
• MDR Text Key: 300985802
• Report Number: 9610816-2022-00501
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• 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 Catalogue Number: UNK238-PIIC
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2010
• 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