MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR

Model Number 865071

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient was being moved to another room and the mother sustained a ruptured uterus.

Manufacturer Narrative

Following allegations were made by (b)(6): fetal death, code 333, moving baby to resus room, ruptured uterus for mother.Philips data analytics team provided complaint search data results on the following parameters:"trackwise query: closed prs included"; "initiate date: after 09/01/2016;" "catalog item identifier: 865071", "scope: complaints".Data search resulted in total of four records from the ottawa hospital that were reported to the ca ((b)(6)) and that alleged death/serious injury.In all of the cases there was no product malfunction of the philips device.Issues were evaluated by the philips engineering research and philips clinical support engineering: difficulty interpreting readings; instructing the customer about the heart measurement of the fetal monitor; there was no malfunction of the philips device.Sn (b)(6).Cross channel verification (ccv) assistance; instructing the customer about ccv functionality; the issue was not caused by a malfunction of the device.Sn (b)(6).The customer is requesting clinical support regarding the cross channel verification (ccv); this issue was resolved by instructing the customer; no malfunction of the device.Sn (b)(6).The customer requested clinical support regarding the cross channel verification (ccv); this issue was resolved by instructing the customer; the issue was not caused by a malfunction of the device.Sn (b)(6).Furthermore, manager for clinical specialist hospital patient monitoring for philips canada stated that the customer has been trained accordingly on the proper use of the philips devices.Several attempts (on 13-dec-2021, 16-dec-2021 and 21-dec-2021) were made by the canada key market to gather additional information from the customer regarding reported issues specifically: "fetal death", "code 333", "moving baby to resus room ", "ruptured uterus for mother" but none were provided.

Event Description

It was reported that a patient was being moved to another room and the mother sustained a ruptured uterus.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: AVALON FM50 FETAL MONITOR
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12804832
• MDR Text Key: 280704269
• Report Number: 9610816-2021-10491
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140535
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• 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