MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-22 for STROLLER manufactured by Caire Inc..
[176210770]
"pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803. 16, neither this report nor any information submitted herein constitutes an admission by caire inc. That the device stated in this report, caire inc. , or caire inc. 's employees, caused or contributed to the reportable event stated herein. " unit has not been returned for an evaluation. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[176210771]
The hospital uses a side fill liberator from vitalaire to fill portables of patients who are present for a consultation. This unit can be used to fill portables from vitalaire or from other providers, depending on the patient. A nurse wanted to help a patient to fill his stroller portable from another provider and suffered a burn to the hand due to a mishandling of the side fill portable and bad knowledge of the side filling procedures; furthermore, the top cover of the stroller was broken and missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2020-00004 |
| MDR Report Key | 9618327 |
| Report Source | FOREIGN |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date Mfgr Received | 2019-11-26 |
| Date Added to Maude | 2020-01-22 |
| 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 Phone | 7707217700 |
| 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 | STROLLER |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2020-01-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2020-01-22 |