• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problems Failure of Device to Self-Test (2937); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported to philips that the heartstart xl exhibited a defective test load.There was no reported patient involvement.
 
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.
 
Manufacturer Narrative
This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl defibrillator indicating that the 50 ohm test load is defective.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the 50 ohm test load is defective.The customer is requesting the part id for the test load to order the part.The customer was made aware the part id is no longer supported by philips and has reached the end of life terms.The heartstart mrx device and all associated service/support was discontinued on (b)(6) 2022.The component is not expected to be returned for additional investigation as no replacement will be provided.The part id was provided to the customer.Device remains at the customer site.As troubleshooting was not completed for the device, the reported issue could not be verified and a cause could not be established.The reported problem was not confirmed.The customer was provided the part id as requested and was made aware of the end of life terms.The device remains at the customer site.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
 
Manufacturer Narrative
This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl defibrillator indicating that the 50 ohm test load is defective.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the 50 ohm test load is defective.The customer is requesting the part id for the test load to order the part.The customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).According to service bulletin (b)(4), the (b)(6) heart/start xl portable defibrillator/monitor was discontinued on (b)(6)2013.All options associated with this defibrillator were discontinued as of (b)(6)2013.The end of support date for the device is (b)(6)2018.The customer was aware of the end of life terms and the device remains at the customer site.The part id was provided to the customer.Device remains at the customer site.As troubleshooting was not completed for the device, the reported issue could not be verified and a cause could not be established.The reported problem was not confirmed.The customer was provided the part id as requested and was made aware of the end of life terms.The device remains at the customer site.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device is end of life / end of support.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEART START XL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
tanya deschmidt
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key18660068
MDR Text Key334772285
Report Number3030677-2024-00495
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM4735A
Device Catalogue NumberM4735A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2024
Initial Date FDA Received02/07/2024
Supplement Dates Manufacturer Received01/18/2024
Not provided
Supplement Dates FDA Received04/01/2024
04/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/19/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-