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
|