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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD SLEEPSTYLE AUTO CPAP; BZD
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FISHER & PAYKEL HEALTHCARE LTD SLEEPSTYLE AUTO CPAP; BZD Back to Search Results
Model Number SPSAAN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Electrical Shock (4018)
Patient Problems Numbness (2415); Electric Shock (2554)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Fisher and paykel heathcare (f&p) is currently in the process of obtaining further information about the reported event.We will provide a follow up report upon completion of our investigation.
 
Event Description
A distributor in canada, via a fisher and paykel healthcare (f&p) representative, reported that while using a sleepstyle auto cpap, a patient received an electrical discharge.The patient experienced numbness in her arm for 30 minutes and had a mark left on her wrist from a silver bracelet she was wearing.No further patient consequences was reported.
 
Event Description
A distributor in canada, via a fisher and paykel healthcare (f&p) representative, reported that while using a sleepstyle auto cpap, a patient received an electrical discharge.The patient experienced numbness in her arm for 30 minutes and had a mark left on her wrist from a silver bracelet she was wearing.No medical intervention was necessary.No further patient consequences were reported.
 
Manufacturer Narrative
(b)(4).Method: the complaint sleepstyle auto cpap was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected, and performance tested.Results: visual inspection of the complaint sleepstyle's power cord, heated breathing tube, power socket and pcb board revealed that there was no fault with the device.The unit was tested for 5 hours and performed as intended.Conclusion: we are unable to determine the cause of the reported fault as there was no fault found with the returned device.The sleepstyle auto cpap is designed to the electrical safety standard iec60601-1 - medical electrical equipment- part 1: general requirements for basic safety and essential performance.Our user instructions that accompany the sleepstyle also state the following: "to avoid electric shock: do not use if the device, power cord or accessories are damaged, deformed, or cracked.Do not pull on the power cord as it may become damaged.Do not use bleach, alcohol, or cleaners with citrus or other natural oils.These substances may degrade the device and accessories.Do not immerse the device in water or any other liquid.Do not modify the device or accessories.Do not take apart the device.Taking the device apart, for example by unscrewing the underside of the device, will damage pressure seals and electrical components.".
 
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Brand Name
SLEEPSTYLE AUTO CPAP
Type of Device
BZD
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key15246703
MDR Text Key298218757
Report Number9611451-2022-00759
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K173193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSPSAAN
Device Catalogue NumberSPSAAN
Device Lot Number2100364175
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexFemale
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