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

Catalog Number UNK013-BEDSIDE MEASUREMENT

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

Further evaluation confirmed that this case is a duplicate of (b)(4) reference mfr report number: 9610816-2022-00500.

• Brand Name: UNKNOWN PATIENT MONITORING BEDSIDE MEASUREMENT
• Type of Device: UNKNOWN PATIENT MONITORING BEDSIDE MEASUREMENT
• 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: 15520954
• MDR Text Key: 300985773
• Report Number: 9610816-2022-00502
• 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 Health Care Professional
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK013-BEDSIDE MEASUREMENT
• Is the Reporter a Health Professional?: Yes
• 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