FDA Adverse Event Malfunction Summary report: N

QUICKIE 2 LITE

MDR report key: 6902365 · Received September 28, 2017

Report

Report Number: 2937137-2017-00029
Event Type: Malfunction
Date Received: September 28, 2017
Date of Event: October 22, 2015
Report Date: October 22, 2015
Manufacturer: SUNRISE MEDICAL (US) LLC
Product Code: IOR
PMA / PMN Number: K072153
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SUNRISE MEDICAL RECEIVED DAMAGED PARTS AND AN EVALUATION WAS COMPLETED BY A QUALITY INVESTIGATOR ON 12/4/2015. THE FOLLOWING RESULTS WERE FOUND: THE SPLINES APPEAR TO BE DAMAGED. THE HOUSING BOLTS ARE LOOSE AND IT MAY BE THE CAUSE OF THE CASTERS COMING OFF. CANNOT CONFIRM IF THE FAILURE WAS A MAINTENANCE ISSUE OR NOT. WILL ACCOMMODATE PARTS UNDER WARRANTY. REPLACEMENT PARTS SHIPPED ON 11/12/2015. THIS ELECTRONIC MDR IS BEING SUBMITTED TO FDA FOLLOWING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY SUNRISE MEDICAL, INC. AS PART OF A CORRECTIVE AND PREVENTIVE ACTION DISCUSSED WITH FDA IN RESPONSE TO AN INSPECTIONAL OBSERVATION. THE REVIEW REQUIRED A DOCUMENTED REASSESSMENT OF EACH COMPLAINT FOR REPORTABILITY UNDER 21 CFR PART 803. AS A RESULT OF THE ASSESSMENT, THIS EVENT WAS IDENTIFIED AS MEETING THE REGULATORY REPORTING CRITERIA IN THE COMPANY'S CURRENT MDR PROCEDURE, AND IS BEING SUBMITTED TO FDA OUT OF AN ABUNDANCE OF CAUTION AND COMPLIANCE TO AID IN PROVIDING FDA WITH UP-TO-DATE INFORMATION.

Description of Event or Problem · 1

PER DEALER, (B)(6), CASTER HOUSING FELL APART WHEN USER WAS IN THE WHEELCHAIR AND BUMPED HIS HEAD. NO TREATMENT NEEDED PER DEALER. USER IS IN A NURSING FACILITY ON CARPET AND HARDWOOD FLOORS. PER DEALER BOTH CASTER HOUSINGS KEEP COMING LOOSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
681300	QUICKIE 2 LITE	MANUAL WHEELCHAIR	IOR	SUNRISE MEDICAL (US) LLC	EIQ2N

Patients

Seq	Age	Sex	Outcome	Treatment
1