HeartStart XL+ Defibrillator/Monitor · Defibrillator
Philips North America LLC · Failure of Device to Self-Test
- Manufacturer contact t name
- Ms.
- Manufacturer contact state
- WA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Bothell
- Manufacturer contact address 1
- 22100 Bothell Everett Highway
- Manufacturer contact pcity
- +1(909)5
- Event type
- Malfunction
- Report number
- 3030677-2026-100925
- Product problem flag
- Y
- Date received
- 20260831
- PMA pmn number
- K110825
- Date of event
- 20260817
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 98021
- Manufacturer contact plocal
- +1(909)570-3538
- Noe summarized
- 1
- Manufacturer contact l name
- HEILING
- Manufacturer g1 postal code
- 98021
- Manufacturer g1 state
- WA
- Reporter country code
- CH
- Date added
- 20260831
- Manufacturer contact f name
- MARIA
- Device date of manufacturer
- 20140411
- Previous use code
- R
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260831
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260831
- Manufacturer g1 country
- US
- Manufacturer contact city
- Bothell
- MDR report key
- 50515027
- Date manufacturer received
- 20260817
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 98021
- Manufacturer g1 name
- Philips North America LLC
- Adverse event flag
- N
- Single use flag
- N
- Manufacturer g1 address 1
- 22100 Bothell Everett Highway
- Manufacturer contact postal code
- 98021
- Type of report
- Initial submission
- Source type
- Foreign, User facility
- Device
- Device sequence number
- 253325
- Serviced by 3rd party flag
- N
- Date received
- 20260831
- Brand name
- HeartStart XL+ Defibrillator/Monitor
- Generic name
- Defibrillator
- Manufacturer d name
- Philips North America LLC
- Manufacturer d address 1
- 22100 Bothell Everett Highway
- Manufacturer d city
- Bothell
- Manufacturer d state
- WA
- Manufacturer d zip code
- 98021
- Manufacturer d country
- US
- Manufacturer d postal code
- 98021
- Model number
- 861290
- Catalog number
- 861290
- Device availability
- Yes
- Device report product code
- MKJ
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 00884838023680
- UDI public
- (01)00884838023680
- Harmonized identifiers (openFDA)
- Device name
- Automated External Defibrillators (Non-Wearable)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.5310
- Device class
- 3
- Product problems
- Failure of Device to Self-Test
- Patient
- Patient sequence number
- 1
- Date received
- 20260831
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions