MAUDE Adverse Event Report: DOLOMITE JAZZ STANDARD ROLLATOR 9153653681; WALKER, MECHANICAL

Model Number NA:JAZZSTD

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware of this event that occurred in (b)(6) involving a jazz rollator.Invacare is filing this report because the device is also marketed and sold in the u.S.The rollator was around 7 years old at the time of the incident and had therefore already exceeded its expected service life.The expected service life of this product is five years when used in accordance with the safety instructions, maintenance intervals and correct use, stated in the user manual.The effective product life cycle can vary according to frequency and intensity of use.The breakage of the front fork is consistent with results of impact, overload followed by material fatigue.The combination of multiple stress factors by transportation and usage may have been affecting the fork over the long time of usage beyond the expected service life, with the consequence of a breakage.Should additional information become available, a supplemental record will be filed.

Event Description

The fork of the jazz rollator broke on a plane track, the patient fell and was admitted to the hospital.No further information about the injury has been received.

• Brand Name: JAZZ STANDARD ROLLATOR 9153653681
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; diö, sweden 343 7 1; SW 343 71
• Manufacturer (Section G): DOLOMITE; växjövägen 303; diö 343 7 1; SW 343 71
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9681464
• MDR Text Key: 189154263
• Report Number: 9615290-2020-00002
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: NA:JAZZSTD
• Device Catalogue Number: JAZZSTD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 66