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

Model Number UNK013-BEDSIDE MONITOR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

The customer reported that central monitoring went down for 12 minutes and an unspecified patient incident occurred on an unknown patient monitoring device.

Manufacturer Narrative

This supplemental report is submitted with reference to manufacturer's report to provide additional and corrected data.

• Brand Name: UNKNOWN PATIENT MONITORING BEDSIDE MONITOR
• Type of Device: UNKNOWN PATIENT MONITORING BEDSIDE MONITOR
• 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: 15718617
• MDR Text Key: 302917300
• Report Number: 9610816-2022-00552
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK013-BEDSIDE MONITOR
• Device Catalogue Number: UNK013-BEDSIDE MONITOR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention