Arjohuntleigh Maxi Sky 2 User Manual

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Arjohuntleigh Maxi Sky 2
Arjohuntleigh Maxi Sky 2 Service Manual

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

ARJOHUNTLEIGH MAGOG INC. MAXI SKY 2 MANUFACTURED CEILING FIXED CASSETTE

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Model Number MS000-01-01

Device Problem Appropriate Term/Code Not Available

Event Date 11/03/2012

Event Type Malfunction

Event Description

While getting a pt up to the chair with a ceiling lift and a loop sling, the right leg loop of the sling unhooked from the spreader bar, causing the pt's leg to drop. This happened when the pt was raised from the bed, so no injuries were sustained.

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Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh on behalf of the mfr arjohuntleigh (b)(4). Add'l info will be provided following the conclusion of the mfr's investigation.

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Arjohuntleigh Maxi Sky 2

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Arjohuntleigh Maxi Sky 2 Service Manual

Type of Device

MANUFACTURED CEILING FIXED CASSETTE

Manufacturer (Section D)

ARJOHUNTLEIGH MAGOG INC.

2001 tanguay st.

magog, quebec J1X 5Y5

CA J1X 5Y5

Manufacturer (Section G)

ARJOHUNTLEIGH MAGOG INC.

2001 tanguay st.

magog, quebec J1X 5Y5

CA J1X 5Y5

Manufacturer Contact

steve kahn

2349 west lake st.

addison , IL 60101

8003231245

MDR Report Key

2862281

Report Number

9681684-2012-00097

Device Sequence Number

Product Code

FNG

Report Source

Manufacturer

Source Type

User facility

Reporter Occupation

Type of Report

Initial

Report Date

11/28/2012,11/05/2012

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

Date FDA Received

11/29/2012

Is This An Adverse Event Report?

Is This A Product Problem Report?

Yes

Device Operator

HEALTH PROFESSIONAL

Device MODEL Number

MS000-01-01

Was Device Available For Evaluation?

Yes

Was the Report Sent to FDA?

Yes

Date Report Sent to FDA

11/28/2012

Distributor Facility Aware Date

11/05/2012

Date Report TO Manufacturer

11/28/2012

Date Manufacturer Received

11/05/2012

Was Device Evaluated By Manufacturer?

Device Not Returned To Manufacturer

Date Device Manufactured

06/01/2012

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Reuse