MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC ZIPPIE TS; MANUAL WHEELCHAIR

Model Number	ZIPPIE TS
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Caregiver reported that the end user was being pushed in his manual wheelchair at school when the wheel came off.Caregiver reported a fall with "quite nasty cuts and bruises, but thankfully no broken bones or concussion." medical attention was not reported.
Additional Manufacturer Narrative
Background information: gl501f8, rev b, tables of harms and severities for manual wheelchairs, "sprains / jams grade 1; pain moderate; bruises; cuts, lacerations, gashes and tears not requiring stitches" as falling to the side (most likely direction of fall due to one wheel falling off).Highest severity reported as 2-minor.Zippie iris owner manual (mk-100151, rev.D, page 4, section g) states "3.Check to see that both quick-release rear axles are locked.When locked, the axle button will "pop out" fully.If not locked, the wheel may come off and cause you to fall.If you fail to heed these warnings, damage to your chair, a fall, tip-over or loss of control may occur and cause severe injury to the rider or others." zippie iris owner manual (page 12, section j) states "j.Quick-release axles: warning! 1.Do not use this chair unless you are sure that both quick-release rear axles are locked.2.An axle is not locked until the quick-release button pops out fully.If the axle is not inserted fully, the wheel may come off during use, endangering the rider.3.Quick-release axles should be periodically cleaned and inspected for function, and signs of wear or bending.Replace as necessary.If you fail to heed these warnings, damage to your chair, a fall, tip-over or loss of control may occur and cause severe injury to the rider or others." ufmea_manual product_master xlsm, (ver.97, risk id 1.5.19.1.1) states lists the risk due to quick-release wheel not being properly attached by caregiver and fall to side as an acceptable risk (severity = 2:minor, occurrence = 3:improbable/<0.1 to >0.001 per thousand, detectability = 1:almost certain); level = 6: corrective action is not required.Discussion: pursuant to requirements of 21 cfr 803.50, subpart #, this event, lacking serious injury, is not a reportable incident.However, since the severity of the injury cannot be ascertained by the description, this report is being filed out of an abundance of caution.Conclusion: given that a product function is for wheels to be removable, and given that there was no reporting about any issue with the quick-release axles which permit the wheels to be removed, it is most likely that the chair functioned as intended.While there is no requirement to file this report, it is being filed out of an abundance of caution due to the report of "quite nasty cuts and bruises" that may or may not have required medical intervention.There is no requirement to file any similar incident in the future, unless there is a report of serious injury.Sunrise medical considers this matter closed.
Additional Manufacturer Narrative
This follow-up correction is being filed due to the product brand name and catalog number being incorrect.The product involved in this complaint was a zippie ts (not a zippie iris) and catalog number is eiz1a (not eiz5a as previously reported).All other information in this filing other than references to the brand name and catalog number are still correct.
Event or Problem Description
Caregiver reported that the end user was being pushed in his manual wheelchair at school when the wheel came off.Caregiver reported a fall with "quite nasty cuts and bruises, but thankfully no broken bones or concussion." medical attention was not reported.

• Brand Name: ZIPPIE TS
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 12586812
• Report Number: 9616084-2021-00059
• Device Sequence Number: 3694818
• Product Code: IOR
• UDI-Device Identifier: 00016958048957
• UDI-Public: (01)00016958048957(12)Z1A-042794
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: ZIPPIE TS
• Device Catalogue Number: EIZ1A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown