MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-12 for POWERED WHEELCHAIR SYSTEM MPPS MPSS manufactured by Motion Concepts Lp.
[185977532]
The complaint for the reported adverse event was received at motion concepts on 12-feb-2020. The subject modular power standing (mps) system was shipped to from motion concepts to medbloc inc. (distributor) on 22-jan-2020 and was subsequently shipped the dealer (after the fall). Following the incident with mr. Tanner (end user), the mps system remained with the dealer. In lieu of having the mps system returned to motion concepts for investigation, it was agreed to send a seating system specialist, phillip mott, to inspect and assess the mps system at the dealer. The subject mps system was inspected by phillip mott. Following his inspection, phillip mott reported that the dealer had adjusted (lowered) the back from its original set-up position. The dealer stated that this adjustment was made after the alleged incident. The recommended back gap for our mps systems (as stated on the motion concepts order form) is 8". Upon inspection of the mps system at the dealer, the measured gap between the back pan and the seat pan measured 5. 5". It was also indicated during the inspection that the end user wished to lower the back height even further as well as shorten the seat depth. Both these adjustments would not be recommended as this would compromise the proper function of the mps system and increase the potential for pinching at the gap between the back pan and the seat pan. It was also noted that a third-party seat cushion was installed on the subject mps system measuring approximately 2-3" in thickness. It was reported that the end user did not have any knowledge of this abrasion until it was noticed by his wife at a later time. During a visit to their family doctor, the doctor indicated that the abrasion may have been caused by a pinch. From this conversation, it was inferred that the abrasion may have been caused by the subject wheelchair. At this time, based on the mix of information we have received from the seating system specialist, the dealer and the end user, we are not able to isolate the root cause of the issue. Motion concepts is continuing to investigate this incident in order to ascertain the root cause. Once we receive more information a follow up report will be submitted to fda regarding this adverse event.
Patient Sequence No: 1, Text Type: N, H10
[185977533]
On 12-feb-2020, motion concepts was notified by medbloc (motion concepts importer) that one of their dealers (after the fall) was notified of an incident that took place on (b)(6) 2020. As per the dealer, the patient's wife discovered that, there was an abrasion on the patient's back and informed it to their family doctor on (b)(6) 2020, who enquired whether there was any day-to-day changes on patients life. The doctor suggested that the abrasion could have caused by a pinch. As the patient received his new wheelchair recently, the patient's wife thinks that the pinch might have been caused when the patient was trying the wheelchair, to which the doctor agreed it was possible. She asked for a seating specialist to inspect the wheelchair before the patient start using it again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615350-2020-00001 |
| MDR Report Key | 9825488 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-10 |
| Device Manufacturer Date | 2020-01-22 |
| Date Added to Maude | 2020-03-12 |
| 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 | MS. DONA BHAMRA |
| Manufacturer Street | 84 CITATION DRIVE UNIT 1-12 |
| Manufacturer City | CONCORD, ONTARIO L4K3C1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4K3C1 |
| Manufacturer G1 | MOTION CONCEPTS LP |
| Manufacturer Street | 84 CITATION DRIVE UNIT 1-12 |
| Manufacturer City | CONCORD, ONTARIO L4K3C1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4K3C1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERED WHEELCHAIR SYSTEM |
| Generic Name | WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-03-12 |
| Model Number | MPPS |
| Catalog Number | MPSS |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOTION CONCEPTS LP |
| Manufacturer Address | 84 CITATION DRIVE UNIT 1-12 CONCORD, ONTARIO L4K3C1 CA L4K3C1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |