MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CC & ANESTHESIA

Model Number 866072

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  malfunction  

Manufacturer Narrative

Medical device: serial number unknown.A follow-up report will be submitted once the investigation is complete.

Event Description

A report from the philips field stated there was an issue with patient allergy data.Patient involvement is unknown at this time.

• Brand Name: INTELLISPACE CC & ANESTHESIA
• Type of Device: INTELLISPACE CC & ANESTHESIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8683834
• MDR Text Key: 147587888
• Report Number: 1218950-2019-04088
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 00884838029286
• UDI-Public: (01)00884838029286
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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