MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR

Model Number 866424

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that a patient was harmed and they requested assistance with the review / collection of retrospective data.The customer stated the issue was a "staff issue" and not a product issue.Philips will consider that the event may be consistent with a serious injury and use of the device may have been a factor.The customer reported only that a patient was harmed but provided no further details regarding the nature of the event.

Manufacturer Narrative

Patient information requested, not available from customer.The issue is not consistent with a malfunction of the product and based upon the information provided by the customer, the device is not deemed to have been a factor in the incident.The customer declined to provide further information and requested closure of the sales force case.No further information was provided; no further action or investigation is warranted.

• Brand Name: PIIC IX HARDWARE
• Type of Device: CENTRAL STATION MONITOR
• 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: 7864149
• MDR Text Key: 119813838
• Report Number: 1218950-2018-07105
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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 Model Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2016
• 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): Required Intervention