MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-10 for H850 H850EU manufactured by Caire Inc..
[144802662]
Unit has been returned for evaluation. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[144802663]
Patient went into town with his wife. He waited at a bus stop (on a bank) wife did grocery shopping. As per the wife she was only gone for ca. 20 minutes. When she came back to her husband the ambulance and emergency doctor was already there. Supposedly the h850 failed and did not deliver any more oxygen. Patient is now in intensive care and received a pacemaker. It took some time for the device to be transferred to the distributor (b)(4) for examination. Examination of the device was done on (b)(6) 2019. Device was technically okay. Device has been returned to caire for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00029 |
| MDR Report Key | 8601644 |
| Report Source | FOREIGN |
| Date Received | 2019-05-10 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2013-09-17 |
| Date Added to Maude | 2019-05-10 |
| 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. NEAL MALOY |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal | 30107 |
| Manufacturer G1 | CAIRE INC. |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | H850 |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-04-24 |
| Model Number | H850EU |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAIRE INC. |
| Manufacturer Address | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 BALL GROUND GA 30107 US 30107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-10 |