APOLLO X-RAY TUBE CEILING NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-17 for APOLLO X-RAY TUBE CEILING NI manufactured by Picker Int'l., Inc..

Event Text Entries

[124301] Extension shaft not mfg to its design spec. Users of apollo ceiling suspensions should determine whether their unit is fitted with an extension shaft. If such a shaft is fitted, the user should contact their svc provider to arrange replacement. The svc provider can then contact picker intl to arrange supply of the replacement parts. If it is necessary to continue use of an apollo fitted with an extension shaft prior to its replacement, users should ensure that the extension shaft is carefully checked by a competent person for any signs of weld deterioration or weld fractures. If there is any doubt over the extension shaft, users should contact their svc provider or picker intl. A small number of apollo ceiling suspensions were fitted with extension shafts either to allow foot and ankle work or where there was a high ceiling. Mda has rec'd a report of an extension shaft failing and investigation revealed that the shaft had not been constructed to the original design spec. Picker has agreed to replace, free of charge, all extension shafts with new shafts to the correct spec.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002119
• MDR Report Key: 149274
• Date Received: 1998-02-17
• Date of Report: 1998-01-01
• Date Added to Maude: 1998-02-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: APOLLO X-RAY TUBE CEILING
• Generic Name: X-RAY TUBE CEILING SUSPENSION
• Product Code: ITY
• Date Received: 1998-02-17
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 145467
• Manufacturer: PICKER INT'L., INC.
• Manufacturer Address: 595 MINER RD. HIGHLAND HGTS. OH 44143 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-02-17