MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH IV REMOTE ALARM DEVICE

Catalog Number M8025-60501

Device Problems Connection Problem (2900); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  Death  

Event Description

The customer reported that a philips monitor was connected incorrectly to the alarm remote box.The nursing staff were told to be careful to connect it properly, but the plug was not specially marked or anything.This resulted in a patient dying because the alarms were not heard while the staff were working at the hospital.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Manufacturer Narrative

H3 other text: the issue was overheard by a company representative and they were unable to get additional details later.

Event Description

Problem statement: it was reported on (b)(6) 2022, that a philips monitor was connected incorrectly to the alarm remote box.The nursing staff were told to be careful to connect it properly, but the plug was not specially marked or anything.This resulted in a patient dying because the alarms were not heard while the staff were working at the hospital.The date of the event is unknown as the reporter stated that he only knows that it was about half a year ago.As the event was reportable to a regulatory authority, an investigation was required.Complaint evaluation: this record is not a re-occurrence of the device failure, but a customer feedback based on a philips employee reporting overhearing a conversation.There is no available product information of devices used at the time of the event.What we have is an educated guess that the affected product is the (453563469801-iv remote alarm device).The reporter stated that "it was not possible to get more information on this case.I am aware that not much can be done with so little information, but the process requires that in any case information concerning equipment, no matter in what context learned, be reported." customer resolution and conclusion: as there was no further information available, the resolution is unknown at this time.No further investigation or action is warranted at this time.Patient/user involvement : was the device being used on a patient at the time of the event, including for the purposes of diagnosis? unknown.Was there any adverse event to the patient or user? if yes, describe? yes.Patient death.If there was an adverse event, did the device cause or contribute to the adverse event, and how? unknown.

• Brand Name: IV REMOTE ALARM DEVICE
• Type of Device: IV REMOTE ALARM DEVICE
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15535977
• MDR Text Key: 301086302
• Report Number: 9610816-2022-00497
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: M8025-60501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Death