MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for PRECISION MEDICAL BM7MFA1001 7MFA1001 manufactured by Precision Medical Inc.
[75940546]
Patient Sequence No: 1, Text Type: N, H10
[75940547]
The dial flowmeters in pacu without float balls are a patient safety issue. If these are set between d? Tentes there is no oxygen flow and no indication that there is no oxygen flow. Anesthesiologist noticed excessive expiratory humidity in his patient's mask and he determined that the flowmeter was sluggish and stuck between settings causing zero o2 flow. Thankfully, the patient maintained spo2 99%. Recommendation was to remove all non float ball flowmeters from service due to faulty design and replace them with flowmeters that use float balls. The dial flowmeters are being discarded. Incidentally, the dial flowmeters do have an indication written on the device that states, "no flow between settings. " this is the manufacturer's warning to users of the issue identified by the anesthesiologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6590229 |
| MDR Report Key | 6590229 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-02-06 |
| Report Date | 2017-05-23 |
| Date Reported to FDA | 2017-05-23 |
| Date Reported to Mfgr | 2017-05-23 |
| Date Added to Maude | 2017-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL |
| Generic Name | DIAL FLOWMETER, OXYGEN |
| Product Code | CAX |
| Date Received | 2017-05-25 |
| Model Number | BM7MFA1001 |
| Catalog Number | 7MFA1001 |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL INC |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |