MAUDE MDR 9850516

MDR report key: 9850516
Report number: 3030677-2020-00530
Event key: 0
Event type: 3
Date received: 2020-03-18
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MRS. DANA TACKETT
Address: 22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	HEARTSTART HOME	AED	PHILIPS MEDICAL SYSTEMS	NSA	M5068A	861282					R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-18	0

Event Narratives#

D

Patient 1

IT HAS BEEN REPORTED THAT THE AED IS NOT FUNCTIONING PROPERLY.

N

Patient 1

THIS ISSUE WAS PREVIOUSLY REPORTED ON PR 10300157 WITH MDR 3030677-2020-00392. THE DEVICE INVESTIGATION IS PENDING.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00884838076716	PHILIPS HeartStart HOME	PHILIPS ELECTRONICS NORTH AMERICA CORPORATION	NSA	2016-05-12
00884838075849	HeartStart	PHILIPS ELECTRONICS NORTH AMERICA CORPORATION	NSA	2016-04-14
00884838023741	PHILIPS HeartStart Adult SMART Pads	PHILIPS ELECTRONICS NORTH AMERICA CORPORATION	NSA	2014-09-24
00884838049130	PHILIPS HeartStart HOME	PHILIPS ELECTRONICS NORTH AMERICA CORPORATION	NSA	2014-09-24
00884838050693	PHILIPS HeartStart OnSite	PHILIPS ELECTRONICS NORTH AMERICA CORPORATION	NSA	2014-09-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K040904	NSA	PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A	Philips Medical Systems	2004-09-16
PMA	P160029S029	NSA	HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)	Philips Medical Systems, Inc.	2026-02-02
PMA	P160029S028	NSA	HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)	Philips Medical Systems, Inc.	2025-06-20
PMA	P160029S027	NSA	HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)	Philips Medical Systems, Inc.	2025-06-09
PMA	P160029S026	NSA	HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS	Philips Medical Systems, Inc.	2024-12-12
PMA	P160029S024	NSA	HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A)	Philips Medical Systems, Inc.	2024-02-21