MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLISPACE PERINATAL K LARGE ARCH.

Model Number	867061
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that their patient monitoring system was not alarming.The device was in use.There was no report of any patient or user harm.
Event or Problem Description
Philips received a complaint on the intellispace perinatal k large arch.Indicating that remote (secondary) alarming failed.
Additional Manufacturer Narrative
A philips response service engineer (rse) followed up with the customer about the allegation.The rse emailed the customer (b)(6) client with online surveillance and alarming section from site prep guide.The rse assisted the customer with configuring default alarms for beds to computers.Subsequently, the rse obtained an email from the customer stating the alarming issue was resolved.Results of functional testing indicate no device issue was identified.Based on the information available and the testing conducted, the cause of the reported problem was user error related to configuration.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLISPACE PERINATAL K LARGE ARCH.
• Common Device Name: INTELLISPACE PERINATAL K LARGE ARCH.
• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 16770600
• Report Number: 9610816-2023-00175
• Device Sequence Number: 20429789
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: 00884838084483
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial 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?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 867061
• Device Catalogue Number: 867061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown