MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EFFICIA CM10; PATIENT MONITOR

Model Number 863301

Device Problem Increase in Pressure (1491)

Patient Problem Laceration(s) (1946)

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Section e reporter phone #: (b)(6).

Event Description

When the nurse monitored the patient's blood pressure as usual, she found that the device did not have a blood pressure value.The nurse immediately checked and found that the cuff was still inflating.The cuff was removed immediately, and it was identified the patient's arm had been bleeding.The record reports the patient had lacerations and blood marks.It was reported this was found in time, immediately pacifying the patient's mood and there were no injuries.The hospital equipment department replaced the blood pressure cuff and the equipment returned to normal.

Manufacturer Narrative

Manufacturing site, model # and catalog # were updated.Type of reportable event was updated from serious injury to product problem.Additional information was received which report no medical intervention was required for the sustained injury and no permanent damaged was caused to the patient.It was confirmed there was just a little bit of imprinting that went away with no intervention.Based on the additional information, this injury does not meet criteria for serious injury.The hospital found that the nibp (non-invasive blood pressure) cuff had malfunction and replaced it.It was reported the cuff is manufactured by philips; however, no device information was known.The device was operational after nibp cuff was replaced.

• Brand Name: EFFICIA CM10
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen MA 71034 ; GM 71034
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17700984
• MDR Text Key: 322869167
• Report Number: 1218950-2023-00630
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 863301
• Device Catalogue Number: 863301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2021
• 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