FDA Adverse Event Other Summary report: N

STERIS ST BACK 902, SHOULDER CHAIR

MDR report key: 2061059 · Received February 22, 2011

Report

Report Number: 1221538-2011-00006
Event Type: Other
Date Received: February 22, 2011
Date of Event: October 10, 2010
Report Date: January 24, 2011
Manufacturer: ALLEN MEDICAL SYSTEMS
Product Code: FWZ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE CHAIR WAS REPORTED TO BE REMOVED FROM USE, BUT NO SERIAL NUMBER WAS PROVIDED FOR THE INVESTIGATION. (B)(4) EVALUATED A DEVICE OF THE SAME DESIGN AND COULD NOT GET THE PRODUCT TO FAIL IN ANY WAY WHEN THE USER INSTRUCTIONS WERE FOLLOWED. IN THEIR RESPONSE TO THE HOSPITAL REPORT, STERIS SURGICAL COMMUNICATED THAT THE MOST LIKELY ROOT CAUSE FOR THE INCIDENT WAS THE STAFF'S FAILURE TO LOCK THE PRODUCT IN PLACE PER THE INSTRUCTIONS. WITHOUT PHOTOGRAPHS OF THE PRODUCT CONDITION AND/OR A RETURN FOR EVALUATION, HOWEVER, A CLEAR ROOT CAUSE CANNOT BE DETERMINED. IF ANY NEW SUBSTANTIVE INFORMATION IS PROVIDED ABOUT THE DEVICE OR THIS CLAIM IT WILL BE MADE IN A FOLLOW-UP REPORT.

Description of Event or Problem · 1

ON (B)(6), AN ALLEN REP IN THE (B)(4) WAS CONTACTED BY (B)(4) IN (B)(4) WITH A REPORTED INCIDENT IN (B)(6) INVOLVING AN ALLEN-MANUFACTURED SHOULDER CHAIR DISTRIBUTED BY (B)(4). THE USER FACILITY FILED A REPORT WITH THE NOTIFIED REP IN (B)(6) ((B)(4)). THE REPORT STATES THE BACK OF THE SHOULDER CHAIR SKIPPED GEARS, MOVING DOWNWARD ABOUT 30CM BEFORE COMING TO REST. THE PATIENT-INVOLVED INCIDENT DID NOT RESULT IN AN INJURY. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STERIS ST BACK 902, SHOULDER CHAIR	SHOULDER CHAIR	FWZ	ALLEN MEDICAL SYSTEMS	I-SCFH	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK