MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for PREVALON MAT SYSTEM QC 10 3242 manufactured by Sage Products Llc.
[129351891]
Reporter discarded the involved product; however, returned thirty-three (33) same lot samples. Ten (10) same lot samples were randomly selected. Evaluation of the ten (10) same lot samples revealed no anomalies. The ten (10) same lot samples were inflated multiple times to examine the pattern of inflation. Additional testing was performed with a person on the device during inflation. The evaluation revealed the ten (10) same lot samples inflated correctly. Production history records for the reported lot were reviewed. The lot passed all incoming inspection acceptance criteria. The reporter stated only one caregiver was present and only one of two side rails were raised when the reported issue occurred. The instructions for use were reviewed. The following cautions and warnings are stated in the instructions for use: use of two caregivers to operate the device: page 2: warnings section- patient repositioning should always be performed using at least two caregivers. Page 17: use two caregivers. Use of bedrails when operating device: page 5: warning- make sure bed rails are up and bed brakes are locked to ensure that the patient and mat do not slide off the support surface, which could cause a fall risk. Page 8: warning- to avoid caregiver or patient injury, make sure the bed rails are raised and the bed brakes are locked. Page 8, step 1: lock the bed brakes and raise the bed rails. Page 9: warning- to avoid caregiver or patient injury, make sure the bed rails are raised and the bed brakes are locked. Page 9, step 10: lock the bed brakes and raise the bed rails. Page 17: raise exterior bed rails. Inflate mat. A specific root cause could not be determined. A potential root cause could be user error for not following the instructions for use. Based on the evaluation of the returned same lot samples and review of the manufacturing records, there is insufficient evidence to conclude that the reported issue was attributable to a product defect or manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
[129351892]
Report received of device malfunction. Reporter stated on (b)(6) 2018, the device was placed under a post-operative patient. Reporter stated post-operative x-rays were needed while the patient was lying on the stretcher with the device under him. Reporter stated two nurses were positioned on the right side of the stretcher with the right side railing up. Reporter stated one radiology technician was positioned on the left side of the stretcher with the left side railing down. Reporter stated the device was initially inflated without issue and the radiology technician placed the x-ray board under the patient, between the device and the stretcher. Reporter stated the device was deflated without issue and x-ray images were taken. Reporter stated additional x-ray images were needed. Reporter stated to obtain the additional x-ray images, post-operative staff did not assist the radiology technician with placement of the x-ray board. Reporter stated the radiology technician was positioned on the left side of the stretcher with the left side railing down while the right side of the stretcher had the right side railing up. Reporter stated the radiology technician inflated the device. Reporter stated the right side of the device reportedly inflated faster than the left side of the device. Reporter stated the patient rolled to the left and fell out of the stretcher. Reporter stated the patient fell on top of the radiology technician and both the patient and the radiology technician fell to the floor. Reporter stated the patient was not injured. Reporter stated the radiology technician sustained a non-serious injury and did not require medical intervention. Reporter stated the involved device was discarded; however, same lot samples were available. Reporter returned same lot samples for evaluation. Although requested, no additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001419181-2018-00029 |
| MDR Report Key | 8112368 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2018-07-09 |
| Date Added to Maude | 2018-11-28 |
| 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. HEATHER SIRIANNI |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal | 60013 |
| Manufacturer Phone | 8154554700 |
| Manufacturer G1 | SAGE PRODUCTS LLC |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREVALON MAT SYSTEM QC 10 |
| Generic Name | PREVALON MOBILE AIR TRANSFER SYSTEM |
| Product Code | FMR |
| Date Received | 2018-11-28 |
| Returned To Mfg | 2018-10-30 |
| Model Number | 3242 |
| Catalog Number | 3242 |
| Lot Number | 18005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |