MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-14 for JAZZ STANDARD ROLLATOR 9153653681 NA:JAZZSTD manufactured by Invacare Sweden, Rea (dolomite).
[174960601]
The jazz std rollator was received by invacare and an expanded evaluation completed on 8/13/18. The visual observation of the technician indicated an issue with the left rear caster assembly. The left rear caster fork was bent inward/upward such that the caster was incapable of contacting the floor with the other casters. The right rear caster fork was straight & in good condition. Some abrasions were observed around the center left rear caster hub; an indication it may have contacted an inanimate object. The rest of the rollator appeared to be in good physical condition, free from any apparent defects. Functional testing was limited due to the damaged condition of the left rear caster, however, the rollator could be folded and unfolded. In conclusion, in its "as received" condition, the complaint of one of the rollator's wheels being buckled has been confirmed. , although the cause of the damage could not be confirmed, the invacare technician felt the damage was consistent with excessive mechanical force from the caster contacting an inanimate object while in motion, causing the fork to bend.
Patient Sequence No: 1, Text Type: N, H10
[174960602]
End user's nurse (rn) stated that her patient was walking towards a restaurant with his jazz standard rollator when the unit wobbled causing him to allegedly lose his balance and fall, sustaining abrasions to his left knee and back (left of the spine). The user was taken to the hospital by ambulance for assessment and x-rays confirmed a fractured left posterior rib. The user was not admitted to the hospital nor the er. He was treated and released being prescribed pain medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615290-2020-00001 |
| MDR Report Key | 9588326 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-14 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE SWEDEN, REA (DOLOMITE) |
| Manufacturer Street | VAXJOVAGEN 303 |
| Manufacturer City | DIO 34375 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 34375 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAZZ STANDARD ROLLATOR 9153653681 |
| Generic Name | WALKER/ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2018-08-13 |
| Model Number | NA:JAZZSTD |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE SWEDEN, REA (DOLOMITE) |
| Manufacturer Address | VAXJOVAGEN 303 DIO 34375 SW 34375 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |